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Combination Chemotherapy as First-Line Therapy in Treating Patients With Stage IV Gastric Cancer That Cannot Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00448682
Recruitment Status : Terminated
First Posted : March 19, 2007
Results First Posted : May 13, 2013
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
University of Miami

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastric Cancer
Interventions Drug: Docetaxel
Drug: Floxuridine
Drug: Leucovorin
Drug: Oxaliplatin
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FUdR + Leucovorin + Oxaliplatin + Docetaxel
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title FUdR + Leucovorin + Oxaliplatin + Docetaxel
Hide Arm/Group Description

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 Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
62
(39 to 85)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
7
  28.0%
Male
18
  72.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Number of Patients Achieving Clinical Response
Hide Description Number of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The study data has not been analyzed.
Arm/Group Title FUdR + Leucovorin + Oxaliplatin + Docetaxel
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Rate of Survival
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The study data has not been analyzed.
Arm/Group Title FUdR + Leucovorin + Oxaliplatin + Docetaxel
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants Experiencing Adverse Events
Hide Description Number of participants experiencing adverse events within 1 year of receiving combination therapy of FUDR + Leucovorin + Oxaliplatin + Docetaxel for metastatic gastric adenocarcinoma.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The study data has not been analyzed.
Arm/Group Title FUdR + Leucovorin + Oxaliplatin + Docetaxel
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and non-serious adverse events were not collected/assessed.
 
Arm/Group Title FUdR + Leucovorin + Oxaliplatin + Docetaxel
Hide Arm/Group Description

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.

All-Cause Mortality
FUdR + Leucovorin + Oxaliplatin + Docetaxel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FUdR + Leucovorin + Oxaliplatin + Docetaxel
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FUdR + Leucovorin + Oxaliplatin + Docetaxel
Affected / at Risk (%)
Total   0/0 
The study was terminated prematurely by the University of Miami Institutional Review Board. The results have not been analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bach Ardalan MD
Organization: University of Miami Sylvester Comprehensive Cancer Center
Phone: 305-243-6608
EMail: bardalan@med.miami.edu
Layout table for additonal information
Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT00448682     History of Changes
Other Study ID Numbers: 20040005
SCCC-2003150 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20050983 ( Other Identifier: Western Insitutional Review Board )
First Submitted: March 15, 2007
First Posted: March 19, 2007
Results First Submitted: February 21, 2013
Results First Posted: May 13, 2013
Last Update Posted: February 7, 2017