Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin

Study Overview
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Brief Summary
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In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (  60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to consolidate the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.

Detailed Description
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To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can prolong the overall survival (OS) or the duration of remission in those patients who have achieved CR or PR by P-HDFL regimen To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen for those patients who have either failed to achieve remission or have recurred from P-HDFL chemotherapy To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers

Official Title
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Phase II Trial of Consolidation or Salvage Chemotherapy by Using Weekly Docetaxel/Irinotecan After Cisplatin Plus Weekly 24-Hour Infusion of High-dose 5-Fluorouracil/Leucovorin for Non-resectable Gastric Cancers

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Docetaxel-Irinotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed gastric adenocarcinoma Measurable or evaluable disease No previous C/T Age 16   75 years Karnofsky Performance Status of 60% 4 weeks after R/T Adjuvant C/T: the last dosing of C/T 6 months before enrollment WBC >= 4,000, platelets >= 100K, Creatinine <= 1.5mg/dl and proteinuria <1+, normal serum bil, transaminase <= 3.5x ULN, TG > 70mg/dl Exclusion Criteria: CNS metastasis Patients receive concomitant anti-cancer C/T or R/T Patients who are pregnant and with an expected life expectancy less than 3 months Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A, 2, III<br>Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL | Drug: Docetaxel-Irinotecan<br>* Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks<br>* Other names: Irinotecan (campto, CPT-11);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rates (CR, PR) |  | Confirmed objective response after 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combination, Chemotherapy, Inoperable Gastric Cancer