Trial Outcomes & Findings for Combination Chemotherapy as First-Line Therapy in Treating Patients With Stage IV Gastric Cancer That Cannot Be Removed By Surgery (NCT NCT00448682)
NCT ID: NCT00448682
Last Updated: 2017-02-07
Results Overview
Number of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.
TERMINATED
PHASE2
25 participants
1 year
2017-02-07
Participant Flow
Participant milestones
| Measure |
FUdR + Leucovorin + Oxaliplatin + Docetaxel
Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:
Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.
Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).
There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy as First-Line Therapy in Treating Patients With Stage IV Gastric Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
FUdR + Leucovorin + Oxaliplatin + Docetaxel
n=25 Participants
Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:
Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.
Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).
There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Gender
Female
|
7 Participants
n=5 Participants
|
|
Gender
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The study data has not been analyzed.
Number of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: The study data has not been analyzed.
Patients will be followed for overall survival from date of enrollment to date of death or last contact. The extent of follow up will be described by the range and median for deceased patients and for those alive at last follow up. We will estimate the 1 year survival rates by the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: The study data has not been analyzed.
Number of participants experiencing adverse events within 1 year of receiving combination therapy of FUDR + Leucovorin + Oxaliplatin + Docetaxel for metastatic gastric adenocarcinoma.
Outcome measures
Outcome data not reported
Adverse Events
FUdR + Leucovorin + Oxaliplatin + Docetaxel
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bach Ardalan MD
University of Miami Sylvester Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place