Trial Outcomes & Findings for Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC (NCT NCT00236899)
NCT ID: NCT00236899
Last Updated: 2011-09-27
Results Overview
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
241 participants
Primary outcome timeframe
Baseline up to 49.84 months
Results posted on
2011-09-27
Participant Flow
Participant milestones
| Measure |
Arm A: Docetaxel and Gemcitabine (Tri-weekly)
Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
64
|
58
|
59
|
|
Overall Study
COMPLETED
|
18
|
24
|
14
|
19
|
|
Overall Study
NOT COMPLETED
|
42
|
40
|
44
|
40
|
Reasons for withdrawal
| Measure |
Arm A: Docetaxel and Gemcitabine (Tri-weekly)
Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event (Study Related)
|
1
|
1
|
2
|
1
|
|
Overall Study
Adverse Event (Not Study Related)
|
3
|
3
|
4
|
7
|
|
Overall Study
Death (Study Disease)
|
1
|
4
|
0
|
0
|
|
Overall Study
Death (Not Study Related)
|
2
|
0
|
0
|
0
|
|
Overall Study
Death (Study Drug Toxicity)
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Entry Criteria Exclusion
|
0
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
5
|
2
|
|
Overall Study
Physician Decision
|
7
|
8
|
7
|
6
|
|
Overall Study
Satisfactory Response
|
2
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
18
|
18
|
25
|
23
|
Baseline Characteristics
Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC
Baseline characteristics by cohort
| Measure |
Arm A: Docetaxel and Gemcitabine (Tri-weekly)
n=60 Participants
Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)
n=64 Participants
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
n=58 Participants
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
n=59 Participants
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
56.58 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
56.31 years
STANDARD_DEVIATION 9.84 • n=7 Participants
|
55.78 years
STANDARD_DEVIATION 8.99 • n=5 Participants
|
54.66 years
STANDARD_DEVIATION 10.04 • n=4 Participants
|
55.85 years
STANDARD_DEVIATION 9.76 • n=21 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
241 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
58 participants
n=5 Participants
|
63 participants
n=7 Participants
|
58 participants
n=5 Participants
|
59 participants
n=4 Participants
|
238 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
60 participants
n=5 Participants
|
64 participants
n=7 Participants
|
58 participants
n=5 Participants
|
59 participants
n=4 Participants
|
241 participants
n=21 Participants
|
|
Menopausal Status
Premenopausal
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
16 participants
n=5 Participants
|
21 participants
n=4 Participants
|
73 participants
n=21 Participants
|
|
Menopausal Status
Postmenopausal
|
41 participants
n=5 Participants
|
47 participants
n=7 Participants
|
42 participants
n=5 Participants
|
38 participants
n=4 Participants
|
168 participants
n=21 Participants
|
|
Previous Hormonal Therapy
Yes
|
44 participants
n=5 Participants
|
48 participants
n=7 Participants
|
40 participants
n=5 Participants
|
46 participants
n=4 Participants
|
178 participants
n=21 Participants
|
|
Previous Hormonal Therapy
No
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
13 participants
n=4 Participants
|
62 participants
n=21 Participants
|
|
Previous Hormonal Therapy
Unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Presence or Absence of Visceral Metastases
Absence
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
16 participants
n=5 Participants
|
23 participants
n=4 Participants
|
77 participants
n=21 Participants
|
|
Presence or Absence of Visceral Metastases
Presence
|
41 participants
n=5 Participants
|
45 participants
n=7 Participants
|
42 participants
n=5 Participants
|
36 participants
n=4 Participants
|
164 participants
n=21 Participants
|
|
Number of Participants with Previous Adjuvant/Neoadjuvant Taxane Therapy
Yes
|
21 participants
n=5 Participants
|
24 participants
n=7 Participants
|
12 participants
n=5 Participants
|
19 participants
n=4 Participants
|
76 participants
n=21 Participants
|
|
Number of Participants with Previous Adjuvant/Neoadjuvant Taxane Therapy
No
|
39 participants
n=5 Participants
|
40 participants
n=7 Participants
|
45 participants
n=5 Participants
|
40 participants
n=4 Participants
|
164 participants
n=21 Participants
|
|
Number of Participants with Previous Adjuvant/Neoadjuvant Taxane Therapy
Unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC)
Excellent
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC)
Good
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
14 participants
n=5 Participants
|
13 participants
n=4 Participants
|
59 participants
n=21 Participants
|
|
Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC)
Moderately Good
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
7 participants
n=5 Participants
|
10 participants
n=4 Participants
|
33 participants
n=21 Participants
|
|
Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC)
Neither Good Nor Bad
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
28 participants
n=21 Participants
|
|
Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC)
Rather Poor
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
8 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC)
Poor
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC)
Extremely Poor
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Quality of Life (QOL) using the Rotterdam Symptom Scale Checklist (RSSC)
No Response
|
15 participants
n=5 Participants
|
24 participants
n=7 Participants
|
22 participants
n=5 Participants
|
16 participants
n=4 Participants
|
77 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 49.84 monthsPopulation: Intention to treat (ITT) population is defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 33 participants were censored with 16 (13.68%)in the Weekly arm and 17 (13.71%) participants in the 3 Weekly arm.
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Outcome measures
| Measure |
Treatment Schedule (Weekly)
n=117 Participants
Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Treatment Schedule (3 Weekly)
n=124 Participants
Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Time to Progressive Disease (TTPD) by Treatment Schedule
|
8.33 months
Interval 6.19 to 10.16
|
7.51 months
Interval 5.93 to 8.33
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 49.84 monthsPopulation: ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 33 (13.7%) participants were censored with 17 (13.68%) in the Docetaxel+Gemcitabine arm and 18 (13.71%) in the Paclitaxel+Gemcitabine arm.
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Outcome measures
| Measure |
Treatment Schedule (Weekly)
n=118 Participants
Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Treatment Schedule (3 Weekly)
n=123 Participants
Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Time to Progressive Disease (TTPD) by Treatment Drug
|
7.74 months
Interval 5.57 to 9.8
|
7.80 months
Interval 6.2 to 8.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 51.64 monthsPopulation: Intention to treat (ITT) population defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 109 (45.2%) participants were censored with 53 (45.3%) in the Weekly arm and 56 (45.2%) participants in the 3 Weekly arm.
OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).
Outcome measures
| Measure |
Treatment Schedule (Weekly)
n=117 Participants
Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Treatment Schedule (3 Weekly)
n=124 Participants
Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Overall Survival (OS) by Treatment Schedule
|
21.11 months
Interval 17.28 to 26.75
|
20.95 months
Interval 18.92 to 33.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 51.64 monthsPopulation: ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 109 participants were censored with 55 (46.61%) in the Docetaxel+Gemcitabine arm and 54 (43.90%) in the Paclitaxel+Gemcitabine arm.
OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).
Outcome measures
| Measure |
Treatment Schedule (Weekly)
n=118 Participants
Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Treatment Schedule (3 Weekly)
n=123 Participants
Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Overall Survival (OS) by Treatment Drug
|
19.11 months
Interval 16.59 to 24.0
|
23.80 months
Interval 19.38 to 31.97
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 49.84 monthsPopulation: All randomized patients treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.
Outcome measures
| Measure |
Treatment Schedule (Weekly)
n=117 Participants
Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Treatment Schedule (3 Weekly)
n=124 Participants
Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) by Treatment Schedule
ORR (Complete Response or Partial Response)
|
50.43 percentage of responses
|
33.06 percentage of responses
|
—
|
—
|
|
Overall Response Rate (ORR) by Treatment Schedule
Complete Response
|
6.84 percentage of responses
|
5.65 percentage of responses
|
—
|
—
|
|
Overall Response Rate (ORR) by Treatment Schedule
Partial Response
|
43.59 percentage of responses
|
27.42 percentage of responses
|
—
|
—
|
|
Overall Response Rate (ORR) by Treatment Schedule
Stable Disease
|
23.93 percentage of responses
|
40.32 percentage of responses
|
—
|
—
|
|
Overall Response Rate (ORR) by Treatment Schedule
Progressive Disease
|
21.37 percentage of responses
|
12.90 percentage of responses
|
—
|
—
|
|
Overall Response Rate (ORR) by Treatment Schedule
Not Available
|
0.85 percentage of responses
|
1.61 percentage of responses
|
—
|
—
|
|
Overall Response Rate (ORR) by Treatment Schedule
Not Assessed
|
3.42 percentage of responses
|
12.10 percentage of responses
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 49.84 monthsPopulation: All randomized participants treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.
Outcome measures
| Measure |
Treatment Schedule (Weekly)
n=118 Participants
Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Treatment Schedule (3 Weekly)
n=123 Participants
Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Overall Response Rate(ORR) by Treatment Drug
ORR (Complete Response or Partial Response)
|
43.2 percentage of responses
|
39.8 percentage of responses
|
—
|
—
|
|
Overall Response Rate(ORR) by Treatment Drug
Complete Response
|
5.08 percentage of responses
|
7.32 percentage of responses
|
—
|
—
|
|
Overall Response Rate(ORR) by Treatment Drug
Partial Response
|
38.14 percentage of responses
|
32.52 percentage of responses
|
—
|
—
|
|
Overall Response Rate(ORR) by Treatment Drug
Stable Disease
|
32.20 percentage of responses
|
32.52 percentage of responses
|
—
|
—
|
|
Overall Response Rate(ORR) by Treatment Drug
Progressive Disease
|
17.80 percentage of responses
|
16.26 percentage of responses
|
—
|
—
|
|
Overall Response Rate(ORR) by Treatment Drug
Not Available
|
0.85 percentage of responses
|
1.63 percentage of responses
|
—
|
—
|
|
Overall Response Rate(ORR) by Treatment Drug
Not Assessed
|
5.93 percentage of responses
|
9.76 percentage of responses
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 51.64 monthsPopulation: Intent to treat (ITT) population defined as the population of all randomized participants.
Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module.
Outcome measures
| Measure |
Treatment Schedule (Weekly)
n=59 Participants
Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Treatment Schedule (3 Weekly)
n=62 Participants
Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
n=58 Participants
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
n=59 Participants
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Number of Participants With Serious and Nonserious Adverse Events (AEs)
Nonserious AEs
|
57 participants
|
58 participants
|
53 participants
|
56 participants
|
|
Number of Participants With Serious and Nonserious Adverse Events (AEs)
SAEs
|
9 participants
|
10 participants
|
7 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline up to 51.64 monthsPopulation: Intent to treat (ITT) population defined as all randomized participants.
RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks.
Outcome measures
| Measure |
Treatment Schedule (Weekly)
n=60 Participants
Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Treatment Schedule (3 Weekly)
n=64 Participants
Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
n=58 Participants
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
n=59 Participants
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
No Response
|
30 participants
|
26 participants
|
22 participants
|
25 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
1=Excellent
|
3 participants
|
1 participants
|
2 participants
|
4 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
2=Good
|
13 participants
|
13 participants
|
9 participants
|
5 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
3=Moderately Good
|
6 participants
|
8 participants
|
9 participants
|
9 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
4=Neither Good Nor Bad
|
6 participants
|
7 participants
|
6 participants
|
7 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
5=Rather Poor
|
2 participants
|
3 participants
|
3 participants
|
6 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
6=Poor
|
0 participants
|
3 participants
|
7 participants
|
2 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
7=Extremely Poor
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to 51.64 monthsPopulation: Intent to treat (ITT) population defined as all randomized participants.
RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided.
Outcome measures
| Measure |
Treatment Schedule (Weekly)
n=60 Participants
Arm C, Docetaxel and Gemcitabine (Weekly):
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D, Paclitaxel and Gemcitabine (Weekly):
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Treatment Schedule (3 Weekly)
n=64 Participants
Arm A, Docetaxel and Gemcitabine (3 Weekly):
Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm B, Paclitaxel and Gemcitabine (3 Weekly):
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
n=58 Participants
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
n=59 Participants
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
1=Excellent
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
2=Good
|
7 participants
|
7 participants
|
2 participants
|
4 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
3=Moderately Good
|
2 participants
|
6 participants
|
3 participants
|
2 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
4=Neither Good Nor Bad
|
3 participants
|
6 participants
|
0 participants
|
3 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
5=Rather Poor
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
6=Poor
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
7=Extremely Poor
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
No Response
|
45 participants
|
44 participants
|
49 participants
|
47 participants
|
Adverse Events
Arm A: Docetaxel and Gemcitabine (Tri-weekly)
Serious events: 9 serious events
Other events: 57 other events
Deaths: 0 deaths
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)
Serious events: 10 serious events
Other events: 58 other events
Deaths: 0 deaths
Arm C: Docetaxel and Gemcitabine (Weekly)
Serious events: 7 serious events
Other events: 53 other events
Deaths: 0 deaths
Arm D: Paclitaxel and Gemcitabine (Weekly)
Serious events: 11 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Docetaxel and Gemcitabine (Tri-weekly)
n=59 participants at risk
Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)
n=62 participants at risk
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
n=58 participants at risk
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
n=59 participants at risk
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
3.4%
2/59 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.8%
4/59 • Number of events 4
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
1.7%
1/59 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/59
|
1.6%
1/62 • Number of events 2
|
0.00%
0/58
|
0.00%
0/59
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/59 • Number of events 2
|
0.00%
0/62
|
1.7%
1/58 • Number of events 1
|
0.00%
0/59
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/59
|
0.00%
0/62
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/59
|
0.00%
0/62
|
1.7%
1/58 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
|
General disorders
Fatigue
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
General disorders
General physical health deterioration
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
General disorders
Oedema peripheral
|
0.00%
0/59
|
0.00%
0/62
|
1.7%
1/58 • Number of events 1
|
0.00%
0/59
|
|
General disorders
Pyrexia
|
1.7%
1/59 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/59
|
0.00%
0/62
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/59
|
0.00%
0/62
|
1.7%
1/58 • Number of events 1
|
0.00%
0/59
|
|
Infections and infestations
Device related infection
|
0.00%
0/59
|
0.00%
0/62
|
1.7%
1/58 • Number of events 1
|
0.00%
0/59
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/59
|
0.00%
0/62
|
1.7%
1/58 • Number of events 1
|
0.00%
0/59
|
|
Infections and infestations
Pneumonia
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Infections and infestations
Sepsis syndrome
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Investigations
Weight decreased
|
0.00%
0/59
|
0.00%
0/62
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/59
|
0.00%
0/62
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/59
|
0.00%
0/62
|
1.7%
1/58 • Number of events 1
|
0.00%
0/59
|
|
Nervous system disorders
Memory impairment
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/59
|
1.6%
1/62 • Number of events 2
|
0.00%
0/58
|
0.00%
0/59
|
|
Nervous system disorders
Presyncope
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
2/59 • Number of events 2
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/59
|
0.00%
0/62
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/59
|
0.00%
0/62
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/59
|
0.00%
0/62
|
1.7%
1/58 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/59
|
0.00%
0/62
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
0.00%
0/58
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
|
Vascular disorders
Hypertension
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Vascular disorders
Vasculitis
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
0.00%
0/58
|
0.00%
0/59
|
Other adverse events
| Measure |
Arm A: Docetaxel and Gemcitabine (Tri-weekly)
n=59 participants at risk
Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)
n=62 participants at risk
Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm C: Docetaxel and Gemcitabine (Weekly)
n=58 participants at risk
Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
Arm D: Paclitaxel and Gemcitabine (Weekly)
n=59 participants at risk
Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.3%
12/59 • Number of events 19
|
16.1%
10/62 • Number of events 13
|
20.7%
12/58 • Number of events 15
|
28.8%
17/59 • Number of events 23
|
|
Blood and lymphatic system disorders
Leukopenia
|
35.6%
21/59 • Number of events 41
|
14.5%
9/62 • Number of events 15
|
24.1%
14/58 • Number of events 35
|
22.0%
13/59 • Number of events 30
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.1%
3/59 • Number of events 5
|
3.2%
2/62 • Number of events 3
|
5.2%
3/58 • Number of events 5
|
3.4%
2/59 • Number of events 5
|
|
Blood and lymphatic system disorders
Neutropenia
|
84.7%
50/59 • Number of events 154
|
53.2%
33/62 • Number of events 85
|
34.5%
20/58 • Number of events 71
|
64.4%
38/59 • Number of events 90
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.8%
4/59 • Number of events 4
|
4.8%
3/62 • Number of events 6
|
17.2%
10/58 • Number of events 25
|
20.3%
12/59 • Number of events 19
|
|
Eye disorders
Conjunctivitis
|
1.7%
1/59 • Number of events 1
|
3.2%
2/62 • Number of events 2
|
6.9%
4/58 • Number of events 5
|
6.8%
4/59 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
4/59 • Number of events 4
|
11.3%
7/62 • Number of events 7
|
5.2%
3/58 • Number of events 4
|
3.4%
2/59 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.5%
5/59 • Number of events 5
|
6.5%
4/62 • Number of events 4
|
8.6%
5/58 • Number of events 6
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
13.6%
8/59 • Number of events 8
|
14.5%
9/62 • Number of events 10
|
17.2%
10/58 • Number of events 16
|
15.3%
9/59 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhoea
|
30.5%
18/59 • Number of events 27
|
17.7%
11/62 • Number of events 13
|
36.2%
21/58 • Number of events 37
|
23.7%
14/59 • Number of events 24
|
|
Gastrointestinal disorders
Gastritis
|
5.1%
3/59 • Number of events 3
|
0.00%
0/62
|
3.4%
2/58 • Number of events 3
|
0.00%
0/59
|
|
Gastrointestinal disorders
Nausea
|
42.4%
25/59 • Number of events 38
|
33.9%
21/62 • Number of events 34
|
34.5%
20/58 • Number of events 34
|
35.6%
21/59 • Number of events 33
|
|
Gastrointestinal disorders
Stomatitis
|
16.9%
10/59 • Number of events 13
|
4.8%
3/62 • Number of events 4
|
13.8%
8/58 • Number of events 10
|
3.4%
2/59 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
22.0%
13/59 • Number of events 18
|
16.1%
10/62 • Number of events 17
|
19.0%
11/58 • Number of events 17
|
6.8%
4/59 • Number of events 6
|
|
General disorders
Asthenia
|
28.8%
17/59 • Number of events 34
|
29.0%
18/62 • Number of events 28
|
31.0%
18/58 • Number of events 40
|
25.4%
15/59 • Number of events 28
|
|
General disorders
Fatigue
|
25.4%
15/59 • Number of events 18
|
19.4%
12/62 • Number of events 16
|
22.4%
13/58 • Number of events 24
|
30.5%
18/59 • Number of events 28
|
|
General disorders
Influenza like illness
|
1.7%
1/59 • Number of events 1
|
0.00%
0/62
|
5.2%
3/58 • Number of events 3
|
0.00%
0/59
|
|
General disorders
Mucosal inflammation
|
28.8%
17/59 • Number of events 26
|
11.3%
7/62 • Number of events 8
|
17.2%
10/58 • Number of events 11
|
10.2%
6/59 • Number of events 9
|
|
General disorders
Oedema
|
3.4%
2/59 • Number of events 2
|
3.2%
2/62 • Number of events 2
|
10.3%
6/58 • Number of events 7
|
6.8%
4/59 • Number of events 5
|
|
General disorders
Oedema peripheral
|
1.7%
1/59 • Number of events 1
|
3.2%
2/62 • Number of events 3
|
6.9%
4/58 • Number of events 6
|
10.2%
6/59 • Number of events 9
|
|
General disorders
Pyrexia
|
28.8%
17/59 • Number of events 22
|
25.8%
16/62 • Number of events 27
|
39.7%
23/58 • Number of events 32
|
28.8%
17/59 • Number of events 38
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/59
|
1.6%
1/62 • Number of events 2
|
0.00%
0/58
|
6.8%
4/59 • Number of events 4
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
6.8%
4/59 • Number of events 5
|
3.2%
2/62 • Number of events 2
|
0.00%
0/58
|
0.00%
0/59
|
|
Infections and infestations
Cystitis
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
5.2%
3/58 • Number of events 3
|
3.4%
2/59 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
18.6%
11/59 • Number of events 18
|
22.6%
14/62 • Number of events 28
|
29.3%
17/58 • Number of events 46
|
33.9%
20/59 • Number of events 30
|
|
Investigations
Aspartate aminotransferase increased
|
13.6%
8/59 • Number of events 10
|
19.4%
12/62 • Number of events 13
|
20.7%
12/58 • Number of events 25
|
22.0%
13/59 • Number of events 21
|
|
Investigations
Blood alkaline phosphatase increased
|
5.1%
3/59 • Number of events 5
|
1.6%
1/62 • Number of events 1
|
5.2%
3/58 • Number of events 4
|
5.1%
3/59 • Number of events 3
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.7%
1/59 • Number of events 2
|
0.00%
0/62
|
0.00%
0/58
|
5.1%
3/59 • Number of events 4
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.7%
1/59 • Number of events 1
|
6.5%
4/62 • Number of events 4
|
5.2%
3/58 • Number of events 4
|
6.8%
4/59 • Number of events 5
|
|
Investigations
Haemoglobin decreased
|
5.1%
3/59 • Number of events 6
|
3.2%
2/62 • Number of events 2
|
5.2%
3/58 • Number of events 3
|
13.6%
8/59 • Number of events 9
|
|
Investigations
Neutrophil count decreased
|
5.1%
3/59 • Number of events 8
|
4.8%
3/62 • Number of events 7
|
3.4%
2/58 • Number of events 2
|
11.9%
7/59 • Number of events 9
|
|
Investigations
Platelet count decreased
|
1.7%
1/59 • Number of events 1
|
4.8%
3/62 • Number of events 3
|
8.6%
5/58 • Number of events 9
|
5.1%
3/59 • Number of events 5
|
|
Investigations
White blood cell count decreased
|
6.8%
4/59 • Number of events 15
|
8.1%
5/62 • Number of events 16
|
1.7%
1/58 • Number of events 2
|
11.9%
7/59 • Number of events 12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/59
|
1.6%
1/62 • Number of events 1
|
8.6%
5/58 • Number of events 5
|
8.5%
5/59 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
3/59 • Number of events 3
|
3.2%
2/62 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
5.1%
3/59 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/59 • Number of events 1
|
9.7%
6/62 • Number of events 6
|
3.4%
2/58 • Number of events 2
|
3.4%
2/59 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/59 • Number of events 1
|
3.2%
2/62 • Number of events 2
|
5.2%
3/58 • Number of events 4
|
5.1%
3/59 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.9%
10/59 • Number of events 13
|
17.7%
11/62 • Number of events 16
|
15.5%
9/58 • Number of events 13
|
11.9%
7/59 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.6%
8/59 • Number of events 11
|
21.0%
13/62 • Number of events 17
|
6.9%
4/58 • Number of events 9
|
8.5%
5/59 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/59 • Number of events 2
|
9.7%
6/62 • Number of events 7
|
5.2%
3/58 • Number of events 3
|
10.2%
6/59 • Number of events 8
|
|
Nervous system disorders
Dysgeusia
|
3.4%
2/59 • Number of events 3
|
9.7%
6/62 • Number of events 7
|
5.2%
3/58 • Number of events 3
|
6.8%
4/59 • Number of events 7
|
|
Nervous system disorders
Headache
|
1.7%
1/59 • Number of events 1
|
12.9%
8/62 • Number of events 10
|
12.1%
7/58 • Number of events 8
|
10.2%
6/59 • Number of events 7
|
|
Nervous system disorders
Neuropathy peripheral
|
3.4%
2/59 • Number of events 2
|
6.5%
4/62 • Number of events 5
|
0.00%
0/58
|
1.7%
1/59 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
6.8%
4/59 • Number of events 5
|
21.0%
13/62 • Number of events 13
|
13.8%
8/58 • Number of events 11
|
13.6%
8/59 • Number of events 9
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.4%
2/59 • Number of events 3
|
12.9%
8/62 • Number of events 11
|
0.00%
0/58
|
10.2%
6/59 • Number of events 8
|
|
Psychiatric disorders
Anxiety
|
3.4%
2/59 • Number of events 2
|
3.2%
2/62 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
4/59 • Number of events 5
|
6.5%
4/62 • Number of events 5
|
6.9%
4/58 • Number of events 6
|
10.2%
6/59 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
3/59 • Number of events 3
|
6.5%
4/62 • Number of events 4
|
5.2%
3/58 • Number of events 6
|
11.9%
7/59 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/59
|
3.2%
2/62 • Number of events 2
|
6.9%
4/58 • Number of events 7
|
3.4%
2/59 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.3%
22/59 • Number of events 22
|
29.0%
18/62 • Number of events 18
|
24.1%
14/58 • Number of events 15
|
27.1%
16/59 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.7%
1/59 • Number of events 1
|
6.5%
4/62 • Number of events 6
|
5.2%
3/58 • Number of events 5
|
1.7%
1/59 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
6.8%
4/59 • Number of events 4
|
1.6%
1/62 • Number of events 1
|
8.6%
5/58 • Number of events 5
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
3/59 • Number of events 3
|
9.7%
6/62 • Number of events 6
|
1.7%
1/58 • Number of events 1
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.2%
6/59 • Number of events 7
|
8.1%
5/62 • Number of events 6
|
5.2%
3/58 • Number of events 3
|
13.6%
8/59 • Number of events 13
|
|
Vascular disorders
Phlebitis
|
3.4%
2/59 • Number of events 3
|
1.6%
1/62 • Number of events 1
|
5.2%
3/58 • Number of events 3
|
3.4%
2/59 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60