Trial Outcomes & Findings for Pemetrexed-Carboplatin and Gemcitabine-Vinorelbine in Advanced Breast Cancer (NCT NCT00325234)
NCT ID: NCT00325234
Last Updated: 2011-05-20
Results Overview
Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants\*100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
Baseline up to 30 days of follow-up after 21 cycles of treatment
Results posted on
2011-05-20
Participant Flow
Participant milestones
| Measure |
Pemetrexed/Carboplatin
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg\*min/mL. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m\^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
66
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
65
|
66
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
69
|
66
|
Reasons for withdrawal
| Measure |
Pemetrexed/Carboplatin
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg\*min/mL. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m\^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
7
|
|
Overall Study
Death due to Study Disease
|
1
|
0
|
|
Overall Study
Entry Criteria Not Met
|
1
|
2
|
|
Overall Study
Subject Decision
|
6
|
8
|
|
Overall Study
Physician Decision
|
17
|
12
|
|
Overall Study
Progressive Disease
|
34
|
37
|
Baseline Characteristics
Pemetrexed-Carboplatin and Gemcitabine-Vinorelbine in Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed/Carboplatin
n=69 Participants
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg\*min/mL. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
n=66 Participants
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m\^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
51.9 years
STANDARD_DEVIATION 11.38 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 10.40 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 10.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
67 participants
n=5 Participants
|
61 participants
n=7 Participants
|
128 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 0
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 1
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG 2
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Hormonal Receptor Status
Estrogen and Progesterone Negative
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Hormonal Receptor Status
Estrogen and/or Progesterone Positive
|
49 participants
n=5 Participants
|
44 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Hormonal Receptor Status
Unknown
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2/Neu)
Positive
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2/Neu)
Negative
|
53 participants
n=5 Participants
|
49 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2/Neu)
Not Performed
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Human Epidermal Growth Factor Receptor 2 (HER-2/Neu)
Unknown
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Tumor Differentiation Grade
Grade I
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Tumor Differentiation Grade
Grade II
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Tumor Differentiation Grade
Grade III
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Tumor Differentiation Grade
Unknown
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Pathological Diagnosis
Carcinoma, Ductal, Breast
|
64 participants
n=5 Participants
|
54 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Pathological Diagnosis
Carcinoma, Lobular, Breast
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Pathological Diagnosis
Carcinoma, Inflammatory, Breast
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Pathological Diagnosis
Carcinoma, Mixed Cell, Breast
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Pathological Diagnosis
Other
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days of follow-up after 21 cycles of treatmentPopulation: All randomized patients who qualified for tumor response analysis by the following criteria: Females with histologic or cytologic diagnosis of advanced breast cancer previously treated with anthracyclines and taxanes. No concurrent antitumor therapy. Presence of measurable disease as defined by RECIST. Treatment with at least 1 dose of study drug.
Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants\*100.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=64 Participants
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
n=61 Participants
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m\^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
|---|---|---|
|
Tumor Response Rate
Overall Response
|
26.6 percentage of participants
Interval 16.3 to 39.1
|
29.5 percentage of participants
Interval 18.5 to 42.6
|
|
Tumor Response Rate
Complete Response
|
0.0 percentage of participants
Interval 0.0 to 5.6
|
3.3 percentage of participants
Interval 0.4 to 11.3
|
|
Tumor Response Rate
Partial Response
|
26.6 percentage of participants
Interval 16.3 to 39.1
|
26.2 percentage of participants
Interval 15.8 to 39.1
|
|
Tumor Response Rate
Stable Disease
|
35.9 percentage of participants
Interval 24.3 to 48.9
|
34.4 percentage of participants
Interval 22.7 to 47.7
|
|
Tumor Response Rate
Progressive Disease
|
26.6 percentage of participants
Interval 16.3 to 39.1
|
27.9 percentage of participants
Interval 17.1 to 40.8
|
|
Tumor Response Rate
Unknown
|
10.9 percentage of participants
Interval 4.5 to 21.2
|
8.2 percentage of participants
Interval 2.7 to 18.1
|
SECONDARY outcome
Timeframe: Time of response to progressive disease (up to 19 months)Population: All randomized participants with CR or PR.
DOR-RECIST criteria of (Complete Response \[CR =Disappearance of lesions\] or Partial Response \[PR=≥30% size decrease of lesions\]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease. For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death. For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=17 Participants
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
n=19 Participants
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m\^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
|---|---|---|
|
Duration of Response (DOR)
|
7.7 Months
Interval 4.2 to 12.2
|
7.5 Months
Interval 4.9 to 8.3
|
SECONDARY outcome
Timeframe: Baseline to measured PD (up to 25.1 months)Population: All randomized participants.
Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease. For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death. For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date. For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=69 Participants
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
n=66 Participants
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m\^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
|---|---|---|
|
Time to Progressive Disease (PD)
|
5.1 Months
Interval 4.1 to 8.0
|
5.6 Months
Interval 4.2 to 7.5
|
SECONDARY outcome
Timeframe: Baseline to end of treatment (up to 21.9 months)Population: All randomized participants
TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE). For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date. For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=69 Participants
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
n=66 Participants
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m\^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
|---|---|---|
|
Time To Treatment Failure (TTTF)
|
4.8 Months
Interval 3.3 to 7.0
|
5.1 Months
Interval 3.5 to 6.3
|
SECONDARY outcome
Timeframe: Baseline to response (up to 7.8 months)Population: All randomized participants with CR or PR.
Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first). CR=Disappearance of target lesions lesions. PR=≥30% size decrease of lesions.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=17 Participants
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
n=19 Participants
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m\^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
|---|---|---|
|
Time to Response
|
1.8 Months
Interval 1.6 to 3.3
|
1.8 Months
Interval 1.6 to 3.1
|
SECONDARY outcome
Timeframe: every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)Population: All randomized participants who received at least one dose of study drug.
A listing of adverse events is presented in the Reported Adverse Event Module.
Outcome measures
| Measure |
Pemetrexed/Carboplatin
n=65 Participants
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
n=66 Participants
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m\^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
|---|---|---|
|
Number of Participants With Adverse Events (AE)
Adverse Events
|
64 participants
|
66 participants
|
|
Number of Participants With Adverse Events (AE)
Serious Adverse Events
|
18 participants
|
22 participants
|
Adverse Events
Pemetrexed/Carboplatin
Serious events: 18 serious events
Other events: 64 other events
Deaths: 0 deaths
Gemcitabine/Vinorelbine
Serious events: 22 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed/Carboplatin
n=65 participants at risk
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg\*min/mL. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
n=66 participants at risk
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m\^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
5/65 • Number of events 10
|
1.5%
1/66 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
1/65 • Number of events 1
|
3.0%
2/66 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
4/65 • Number of events 6
|
3.0%
2/66 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.2%
6/65 • Number of events 10
|
0.00%
0/66
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
Vomiting
|
4.6%
3/65 • Number of events 3
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Condition aggravated
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Medical device complication
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Performance status decreased
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
|
General disorders
Pyrexia
|
3.1%
2/65 • Number of events 2
|
4.5%
3/66 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Implant site infection
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
3.1%
2/65 • Number of events 2
|
0.00%
0/66
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Investigations
International normalised ratio increased
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
2/65 • Number of events 2
|
0.00%
0/66
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed/Carboplatin
n=65 participants at risk
Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg\*min/mL. The cycle of treatment was 21 days.
|
Gemcitabine/Vinorelbine
n=66 participants at risk
Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8.
Gemcitabine 1200 mg/m\^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
49.2%
32/65 • Number of events 46
|
42.4%
28/66 • Number of events 36
|
|
Blood and lymphatic system disorders
Leukopenia
|
43.1%
28/65 • Number of events 79
|
53.0%
35/66 • Number of events 84
|
|
Blood and lymphatic system disorders
Lymphopenia
|
15.4%
10/65 • Number of events 13
|
12.1%
8/66 • Number of events 15
|
|
Blood and lymphatic system disorders
Neutropenia
|
56.9%
37/65 • Number of events 120
|
77.3%
51/66 • Number of events 154
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
26.2%
17/65 • Number of events 34
|
16.7%
11/66 • Number of events 23
|
|
Cardiac disorders
Palpitations
|
1.5%
1/65 • Number of events 1
|
7.6%
5/66 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
4.6%
3/65 • Number of events 3
|
13.6%
9/66 • Number of events 12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
5/65 • Number of events 5
|
15.2%
10/66 • Number of events 13
|
|
Gastrointestinal disorders
Constipation
|
27.7%
18/65 • Number of events 24
|
39.4%
26/66 • Number of events 41
|
|
Gastrointestinal disorders
Diarrhoea
|
10.8%
7/65 • Number of events 7
|
18.2%
12/66 • Number of events 14
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
2/65 • Number of events 3
|
9.1%
6/66 • Number of events 7
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
4/65 • Number of events 5
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
47.7%
31/65 • Number of events 48
|
34.8%
23/66 • Number of events 73
|
|
Gastrointestinal disorders
Stomatitis
|
10.8%
7/65 • Number of events 8
|
16.7%
11/66 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
15/65 • Number of events 20
|
22.7%
15/66 • Number of events 19
|
|
General disorders
Asthenia
|
21.5%
14/65 • Number of events 23
|
19.7%
13/66 • Number of events 19
|
|
General disorders
Fatigue
|
35.4%
23/65 • Number of events 38
|
39.4%
26/66 • Number of events 39
|
|
General disorders
Oedema peripheral
|
9.2%
6/65 • Number of events 6
|
9.1%
6/66 • Number of events 7
|
|
General disorders
Pyrexia
|
7.7%
5/65 • Number of events 6
|
31.8%
21/66 • Number of events 33
|
|
Investigations
Alanine aminotransferase increased
|
16.9%
11/65 • Number of events 16
|
31.8%
21/66 • Number of events 30
|
|
Investigations
Aspartate aminotransferase increased
|
13.8%
9/65 • Number of events 14
|
25.8%
17/66 • Number of events 25
|
|
Investigations
Blood alkaline phosphatase increased
|
10.8%
7/65 • Number of events 7
|
10.6%
7/66 • Number of events 8
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.2%
4/65 • Number of events 4
|
16.7%
11/66 • Number of events 16
|
|
Investigations
Weight decreased
|
4.6%
3/65 • Number of events 3
|
12.1%
8/66 • Number of events 8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.3%
8/65 • Number of events 10
|
18.2%
12/66 • Number of events 13
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.6%
3/65 • Number of events 6
|
7.6%
5/66 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
2/65 • Number of events 2
|
7.6%
5/66 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
5/65 • Number of events 5
|
9.1%
6/66 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
4/65 • Number of events 4
|
9.1%
6/66 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/65
|
7.6%
5/66 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
7.7%
5/65 • Number of events 7
|
6.1%
4/66 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
4.6%
3/65 • Number of events 3
|
6.1%
4/66 • Number of events 4
|
|
Nervous system disorders
Headache
|
10.8%
7/65 • Number of events 10
|
16.7%
11/66 • Number of events 16
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.6%
3/65 • Number of events 3
|
13.6%
9/66 • Number of events 14
|
|
Psychiatric disorders
Anxiety
|
1.5%
1/65 • Number of events 1
|
9.1%
6/66 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
9.2%
6/65 • Number of events 6
|
4.5%
3/66 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
5/65 • Number of events 5
|
13.6%
9/66 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
4/65 • Number of events 4
|
9.1%
6/66 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
5/65 • Number of events 6
|
3.0%
2/66 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.3%
8/65 • Number of events 8
|
24.2%
16/66 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.2%
6/65 • Number of events 11
|
10.6%
7/66 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
4/65 • Number of events 4
|
13.6%
9/66 • Number of events 10
|
|
Vascular disorders
Phlebitis
|
0.00%
0/65
|
9.1%
6/66 • Number of events 8
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60