Trial Outcomes & Findings for Gemcitabine in Ovarian Cancer (NCT NCT00191334)
NCT ID: NCT00191334
Last Updated: 2009-03-27
Results Overview
Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up
Results posted on
2009-03-27
Participant Flow
Participant milestones
| Measure |
Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Disease Progression or Relapse
|
8
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Gemcitabine in Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine + Cisplatin
n=50 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.
|
|---|---|
|
Age Continuous
|
54.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
50 participants
n=5 Participants
|
|
Disease Stage
Stage I - Tumor Limited to Ovaries
|
0 participants
n=5 Participants
|
|
Disease Stage
Stage II - Pelvic Extension and/or Implants
|
0 participants
n=5 Participants
|
|
Disease Stage
Stage IIIa - Microscopic Peritoneal Metastasis
|
1 participants
n=5 Participants
|
|
Disease Stage
Stage IIIb - Macroscopic Peritoneal Metastasis
|
3 participants
n=5 Participants
|
|
Disease Stage
Stage IIIc - Peritoneal Metastasis More Than 2 cm
|
21 participants
n=5 Participants
|
|
Disease Stage
Stage IV - Distant Metastases
|
25 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Score
0 - Fully Active
|
28 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Score
1 - Ambulatory, Restricted Strenuous Activity
|
20 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Score
2 - Ambulatory, No Work Activities
|
2 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Score
3 - Partially Confined to Bed, Limited Self Care
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status Score
4 - Completely Disabled
|
0 participants
n=5 Participants
|
|
Postoperational Pathomorphological Diagnosis
Serous Cystadenocarcinoma
|
37 participants
n=5 Participants
|
|
Postoperational Pathomorphological Diagnosis
Mucinosa Cystadenocarcinoma
|
3 participants
n=5 Participants
|
|
Postoperational Pathomorphological Diagnosis
Endometrioid Carcinoma
|
4 participants
n=5 Participants
|
|
Postoperational Pathomorphological Diagnosis
Other
|
6 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
49 participants
n=5 Participants
|
|
Race/Ethnicity
Other
|
1 participants
n=5 Participants
|
|
State of Patient Relative to Menopause
Fertile Period
|
4 participants
n=5 Participants
|
|
State of Patient Relative to Menopause
Post-Menopause
|
46 participants
n=5 Participants
|
|
Time from Initial Diagnosis to Study Entry
|
14.0 days
STANDARD_DEVIATION 10.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-upBest response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=50 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.
|
|---|---|
|
Best Overall Tumor Response
Complete Response
|
6 participants
|
|
Best Overall Tumor Response
Partial Response
|
25 participants
|
|
Best Overall Tumor Response
Stable Disease
|
10 participants
|
|
Best Overall Tumor Response
Progressive Disease
|
5 participants
|
|
Best Overall Tumor Response
Not Assessed
|
4 participants
|
SECONDARY outcome
Timeframe: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-upThe 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=50 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Response
|
37.0 weeks
Interval 31.1 to 51.1
|
SECONDARY outcome
Timeframe: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-upDefined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=50 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Progressive Disease
|
45.1 weeks
Interval 37.9 to 56.9
|
SECONDARY outcome
Timeframe: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-upDefined 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. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=50 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Treatment Failure
|
38.4 weeks
Interval 29.1 to 48.3
|
SECONDARY outcome
Timeframe: every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-upGrades range from 0 (no toxicity) to 4 (life-threatening or disabling).
Outcome measures
| Measure |
Gemcitabine + Cisplatin
n=50 Participants
Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Renal failure - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Patients with at least one CTC - Grade 3
|
2 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Renal failure - Grade 3
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Renal failure - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Renal/genitourinary - Other - Grade 1
|
6 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Renal/genitourinary - Other - Grade 2
|
2 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Renal/genitourinary - Other - Grade 3
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Renal/genitourinary - Other - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Patients with at least one CTC - Grade 1
|
34 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Patients with at least one CTC - Grade 2
|
6 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Patients with at least one CTC - Grade 4
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Other auditory/hearing - Grade 1
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Other auditory/hearing - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Other auditory/hearing - Grade 3
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Other auditory/hearing - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Leukocytes - Grade 1
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Leukocytes - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Leukocytes - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Leukocytes - Grade 4
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Neutrophils/granulocytes - Grade 1
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Neutrophils/granulocytes - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Neutrophils/granulocytes - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Neutrophils/granulocytes - Grade 4
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Fatigue - Grade 1
|
11 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Fatigue - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Fatigue - Grade 3
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Fatigue - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Weight loss - Grade 1
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Weight loss - Grade 2
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Weight loss - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Weight loss - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Alopecia - Grade 1
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Alopecia - Grade 2
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Alopecia - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Alopecia - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Rash/desquamation - Grade 1
|
2 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Rash/desquamation - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Rash/desquamation - Grade 3
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Rash/desquamation - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Anorexia - Grade 1
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Anorexia - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Anorexia - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Anorexia - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Diarrhea (without colostomy) - Grade 1
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Diarrhea (without colostomy) - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Diarrhea (without colostomy) - Grade 3
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Diarrhea (without colostomy) - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Nausea - Grade 1
|
29 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Nausea - Grade 2
|
2 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Nausea - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Nausea - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Other Gastrointestinal - Grade 1
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Other Gastrointestinal - Grade 2
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Other Gastrointestinal - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Other Gastrointestinal - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Stomatitis/pharyngitis - Grade 1
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Stomatitis/pharyngitis - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Stomatitis/pharyngitis - Grade 3
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Stomatitis/pharyngitis - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Vomiting - Grade 1
|
24 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Vomiting - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Vomiting - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Vomiting - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Alkaline phosphatase - Grade 1
|
13 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Alkaline phosphatase - Grade 2
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Alkaline phosphatase - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Alkaline phosphatase - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Bilirubin - Grade 1
|
6 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Bilirubin - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Bilirubin - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Bilirubin - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Serum glutamic oxaloacetic transaminase - Grade 1
|
8 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Serum glutamic oxaloacetic transaminase - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Serum glutamic oxaloacetic transaminase - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Serum glutamic oxaloacetic transaminase - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Serum glutamic pyruvic transaminase - Grade 1
|
7 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Serum glutamic pyruvic transaminase - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Serum glutamic pyruvic transaminase - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Serum glutamic pyruvic transaminase - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Dizziness/lightheadedness - Grade 1
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Dizziness/lightheadedness - Grade 2
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Dizziness/lightheadedness - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Dizziness/lightheadedness - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Headache - Grade 1
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Headache - Grade 2
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Headache - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Headache - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Creatinine - Grade 1
|
7 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Creatinine - Grade 2
|
1 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Creatinine - Grade 3
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Creatinine - Grade 4
|
0 participants
|
|
Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade
Renal failure - Grade 1
|
0 participants
|
Adverse Events
Gemcitabine + Cisplatin
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
1/50 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
2.0%
1/50 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine + Cisplatin
Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.
Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
64.0%
32/50 • Number of events 42
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
25/50 • Number of events 29
|
|
General disorders
Asthenia
|
34.0%
17/50 • Number of events 19
|
|
Infections and infestations
Respiratory tract infection viral
|
8.0%
4/50 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
18.0%
9/50 • Number of events 14
|
|
Investigations
Aspartate aminotransferase increased
|
28.0%
14/50 • Number of events 16
|
|
Investigations
Blood alkaline phosphatase increased
|
30.0%
15/50 • Number of events 15
|
|
Investigations
Blood bilirubin increased
|
16.0%
8/50 • Number of events 9
|
|
Investigations
Blood creatinine increased
|
20.0%
10/50 • Number of events 17
|
|
Investigations
Creatinine renal clearance decreased
|
18.0%
9/50 • Number of events 12
|
|
Investigations
Weight decreased
|
22.0%
11/50 • Number of events 11
|
|
Investigations
Weight increased
|
18.0%
9/50 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
3/50 • Number of events 3
|
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