Back to resultsStudy of Weekly DCF to Treat Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel, Cisplatin, 5-Fu
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring DCF, Advanced gastric cancer, Phase II study, Efficacy, Toxicity
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 70 years
- Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
- ECOG performance status ≤1,life expectancy more than 3 months,
- Normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
- Measurable disease according to the RECIST.
Exclusion Criteria:
- Pregnant or lactating women
- Serious uncontrolled diseases and intercurrent infection
- The evidence of CNS metastasis
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Received other chemotherapy regimen after metastasis
- Used taxane in adjuvant settings
- Participated in other clinical trials.
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
weekly chemo
Arm Description
Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities.
Outcomes
Primary Outcome Measures
Response rate, overall survival
Secondary Outcome Measures
Side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00568971
Brief Title
Study of Weekly DCF to Treat Advanced Gastric Cancer
Official Title
Phase II Study of Weekly Docetaxol Combined With Cisplatin and 5-Fu in Patients With Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
The study has finished.
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of weekly docetaxol combined with cisplatin and 5-Fu in patients with AGC.
Detailed Description
Recently,in a multi-center, open-label randomized phase III study (V325), compared to the control arm of CF regimen, DCF showed higher efficacy in terms of response rate, time to progression and overall survival. But the regimen had increased grade 3-4 neutropenia (82% vs 57%) and febrile neutropenia infection (29% vs 12%). We began to study on weekly DCF in the patients with advanced gastric cancer to evaluate the efficacy no less than that of 3-week' regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
DCF, Advanced gastric cancer, Phase II study, Efficacy, Toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
weekly chemo
Arm Type
Experimental
Arm Description
Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities.
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Cisplatin, 5-Fu
Other Intervention Name(s)
wDCF
Intervention Description
Docetaxel 33.3 mg/m2, Cisplatin 30 mg/m2 and 5-FU 1500 mg/m2 of 24-hour continuous intravenous infusion;d1,8,15 q4w.The treatment will not stopped until disease progression or unaccepted toxicities.
Primary Outcome Measure Information:
Title
Response rate, overall survival
Time Frame
2-6 months
Secondary Outcome Measure Information:
Title
Side effects
Time Frame
2-6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 70 years
Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
ECOG performance status ≤1,life expectancy more than 3 months,
Normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
Measurable disease according to the RECIST.
Exclusion Criteria:
Pregnant or lactating women
Serious uncontrolled diseases and intercurrent infection
The evidence of CNS metastasis
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Received other chemotherapy regimen after metastasis
Used taxane in adjuvant settings
Participated in other clinical trials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of Weekly DCF to Treat Advanced Gastric Cancer
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