Trial Outcomes & Findings for Combination Chemotherapy for Metastatic Breast Cancer (NCT NCT00191815)
NCT ID: NCT00191815
Last Updated: 2009-11-11
Results Overview
Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)
Results posted on
2009-11-11
Participant Flow
Participant milestones
| Measure |
Gemcitabine + Cisplatin
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
Treated
|
67
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Gemcitabine + Cisplatin
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Disease progression or relapse
|
24
|
|
Overall Study
Death
|
2
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
Baseline Characteristics
Combination Chemotherapy for Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine + Cisplatin
n=70 Participants
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Age Continuous
|
50.5 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
|
Menopausal Status
Pre-menopausal
|
16 participants
n=5 Participants
|
|
Menopausal Status
Post-menopausal
|
54 participants
n=5 Participants
|
|
Pathological Diagnosis
Ductal breast carcinoma
|
44 participants
n=5 Participants
|
|
Pathological Diagnosis
Ductal and lobular breast carcinoma
|
2 participants
n=5 Participants
|
|
Pathological Diagnosis
Lobular breast carcinoma
|
5 participants
n=5 Participants
|
|
Pathological Diagnosis
Mucinous breast carcinoma
|
1 participants
n=5 Participants
|
|
Pathological Diagnosis
Adenocystic breast carcinoma
|
10 participants
n=5 Participants
|
|
Pathological Diagnosis
Papillary carcinoma
|
1 participants
n=5 Participants
|
|
Pathological Diagnosis
Unknown
|
7 participants
n=5 Participants
|
|
Stage of Disease at Entry to the Study
Stage IIIb
|
1 participants
n=5 Participants
|
|
Stage of Disease at Entry to the Study
Stage IV
|
69 participants
n=5 Participants
|
|
Stage of Disease at Time of Diagnosis
Stage I
|
3 participants
n=5 Participants
|
|
Stage of Disease at Time of Diagnosis
Stage IIa
|
13 participants
n=5 Participants
|
|
Stage of Disease at Time of Diagnosis
Stage IIb
|
22 participants
n=5 Participants
|
|
Stage of Disease at Time of Diagnosis
Stage IIIa
|
12 participants
n=5 Participants
|
|
Stage of Disease at Time of Diagnosis
Stage IIIb
|
15 participants
n=5 Participants
|
|
Stage of Disease at Time of Diagnosis
Stage IV
|
5 participants
n=5 Participants
|
|
Time from Initial Diagnosis to Study Entry
|
37.6 month
STANDARD_DEVIATION 39.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)Population: Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.
Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=54 Participants
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Objective Tumor Response
Complete Response
|
7 participants
|
|
Objective Tumor Response
Partial Response
|
19 participants
|
|
Objective Tumor Response
Stable Disease
|
19 participants
|
|
Objective Tumor Response
Progressive Disease
|
5 participants
|
|
Objective Tumor Response
Not Assessable
|
4 participants
|
SECONDARY outcome
Timeframe: first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)Population: Response population: all enrolled participants who had either a complete or partial response.
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=26 Participants
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Duration of Response
|
32.7 weeks
Interval 26.9 to 48.6
|
SECONDARY outcome
Timeframe: first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)Population: Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.
Defined as the time from study enrollment to the first date of disease progression.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=54 Participants
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Time to Progressive Disease
|
33.9 weeks
Interval 23.9 to 48.0
|
SECONDARY outcome
Timeframe: first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)Population: Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.
Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=54 Participants
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Time to Treatment Failure
|
26.2 weeks
Interval 19.6 to 34.9
|
SECONDARY outcome
Timeframe: first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)Population: Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.
Overall survival is the duration from enrollment to death due to any cause.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=54 Participants
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Survival Time
|
84.0 weeks
Interval 58.6 to 119.3
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)Population: Safety Population: all enrolled participants who received study drug.
The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=67 Participants
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Allergic reaction/hypersensivity - Grade 1
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Allergic reaction/hypersensivity - Grade 2
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Allergic reaction/hypersensivity - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Allergic reaction/hypersensivity - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Allergic rhinitis - Grade 1
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Allergic rhinitis - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Allergic rhinitis - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Allergic rhinitis - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Other auditory/hearing - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Other auditory/hearing - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Other auditory/hearing - Grade 3
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Other auditory/hearing - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Blood/Bone marrow - other - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Blood/Bone marrow - other - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Blood/Bone marrow - other - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Blood/Bone marrow - other - Grade 4
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Cardiac- ischemia/infarction - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Cardiac- ischemia/infarction - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Cardiac- ischemia/infarction - Grade 3
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Cardiac- ischemia/infarction - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Hypertension - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Hypertension - Grade 2
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Hypertension - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Hypertension - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Hypotension - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Hypotension - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Hypotension - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Hypotension - Grade 4
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Fatigue - Grade 1
|
6 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Fatigue - Grade 2
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Fatigue - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Fatigue - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Fever - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Fever - Grade 2
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Fever - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Fever - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Rigors, chills - Grade 1
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Rigors, chills - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Rigors, chills - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Rigors, chills - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Weight loss - Grade 1
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Weight loss - Grade 2
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Weight loss - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Weight loss - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Alopecia - Grade 1
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Alopecia - Grade 2
|
3 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Alopecia - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Alopecia - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Rash/desquamation - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Rash/desquamation - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Rash/desquamation - Grade 3
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Rash/desquamation - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Anorexia - Grade 1
|
4 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Anorexia - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Anorexia - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Anorexia - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Constipation - Grade 1
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Constipation - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Constipation - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Constipation - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Mucositis due to radiation - Grade 1
|
2 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Mucositis due to radiation - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Mucositis due to radiation - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Mucositis due to radiation - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Nausea - Grade 1
|
10 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Nausea - Grade 2
|
8 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Nausea - Grade 3
|
2 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Nausea - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Vomiting - Grade 1
|
4 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Vomiting - Grade 2
|
7 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Vomiting - Grade 3
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Vomiting - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
SGPT (ALT) - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
SGPT (ALT) - Grade 2
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
SGPT (ALT) - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
SGPT (ALT) - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Infection without neutropenia - Grade 1
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Infection without neutropenia - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Infection without neutropenia - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Infection without neutropenia - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Insomnia - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Insomnia - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Insomnia - Grade 3
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Insomnia - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Abdominal pain or cramping - Grade 1
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Abdominal pain or cramping - Grade 2
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Abdominal pain or cramping - Grade 3
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Abdominal pain or cramping - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Headache - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Headache - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Headache - Grade 3
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Headache - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Pain - Other - Grade 1
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Pain - Other - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Pain - Other - Grade 3
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Pain - Other - Grade 4
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Renal/Genitourinary - Other - Grade 1
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Renal/Genitourinary - Other - Grade 2
|
0 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Renal/Genitourinary - Other - Grade 3
|
1 participants
|
|
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Renal/Genitourinary - Other - Grade 4
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)Population: Safety Population: all enrolled participants who received study drug.
Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death).
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=67 Participants
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Hemoglobin (g/L) - Grade 1
|
35 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Hemoglobin (g/L) - Grade 2
|
20 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Hemoglobin (g/L) - Grade 3
|
5 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Hemoglobin (g/L) - Grade 4
|
1 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Neutrophils (x10E9/L) - Grade 1
|
6 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Neutrophils (x10E9/L) - Grade 2
|
25 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Neutrophils (x10E9/L) - Grade 3
|
13 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Neutrophils (x10E9/L) - Grade 4
|
10 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Platelets (x10E9/L) - Grade 1
|
43 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Platelets (x10E9/L) - Grade 2
|
2 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Platelets (x10E9/L) - Grade 3
|
1 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Platelets (x10E9/L) - Grade 4
|
0 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
White Blood Cells (x10E9/L) - Grade 1
|
16 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
White Blood Cells (x10E9/L) - Grade 3
|
18 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
White Blood Cells (x10E9/L) - Grade 4
|
3 participants
|
|
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
White Blood Cells (x10E9/L) - Grade 2
|
27 participants
|
SECONDARY outcome
Timeframe: Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)Population: All enrolled participants.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=70 Participants
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Number of Deaths
Ventricular Fibrillation
|
1 participants
|
|
Number of Deaths
Circulatory Arrest
|
1 participants
|
|
Number of Deaths
Disease Progression
|
35 participants
|
SECONDARY outcome
Timeframe: Baseline through eight 21-day cyclesPopulation: Safety Population: all enrolled participants who received study drug.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=67 Participants
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Number of Participants With Adverse Events Leading to Discontinuation
Patients with >=1 AE leading to discontinuation
|
2 participants
|
|
Number of Participants With Adverse Events Leading to Discontinuation
Pneumonia
|
1 participants
|
|
Number of Participants With Adverse Events Leading to Discontinuation
Toxic skin eruption
|
1 participants
|
Adverse Events
Gemcitabine + Cisplatin
Serious events: 6 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine + Cisplatin
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/67 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
1.5%
1/67 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
1.5%
1/67 • Number of events 1
|
|
Gastrointestinal disorders
Periproctitis
|
1.5%
1/67 • Number of events 1
|
|
General disorders
General physical health deterioration
|
1.5%
1/67 • Number of events 1
|
|
Infections and infestations
Escherichia sepsis
|
1.5%
1/67 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.5%
1/67 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.5%
1/67 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
1.5%
1/67 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.5%
1/67 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
1/67 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.5%
1/67 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
1.5%
1/67 • Number of events 1
|
|
Vascular disorders
Circulatory collapse
|
1.5%
1/67 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
1.5%
1/67 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine + Cisplatin
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
23.9%
16/67 • Number of events 26
|
|
Gastrointestinal disorders
Nausea
|
34.3%
23/67 • Number of events 46
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
12/67 • Number of events 20
|
|
General disorders
Asthenia
|
20.9%
14/67 • Number of events 29
|
|
Investigations
Weight decreased
|
10.4%
7/67 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.5%
5/67 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
13.4%
9/67 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.0%
6/67 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
5/67 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.0%
4/67 • Number of events 4
|
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