Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer

Study Overview
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Brief Summary
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Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11) gastrointestinal toxicities when the CPT-11 is administered in combination with thalidomide in patients with diagnosis of gastric cancer. The main purpose of this study is to investigate the efficacy and safety of thalidomide and CPT-11 in advanced gastric cancer. The investigators will also manage to find out the possible interactions between CPT-11 pharmacokinetics and thalidomide to explain the previously described gastrointestinal toxicity reduction.

Detailed Description
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This is a prospective, randomized, multi-center, controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide and CPT-11 in advanced gastric cancer. A total of 900 patients are planned to be enrolled into the study. Patients with diagnosis of advanced gastric cancer will be randomized into two groups, and be treated with thalidomide+ CPT-11 or CPT-11, respectively. The primary end point is time to progression (TTP), and the secondary end points include efficacy, overall survival (OS) and the occurrence of delayed diarrhea.

Official Title
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Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer : A Multicenter, Randomized, Controlled and Prospective Trial

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Thalidomide
* Drug: CPT-11


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18y <Age<75y Patients with histologically proven tumor focus will be eligible for this protocol Measurable or assessable disease At least 4 weeks since last chemotherapy ;chemotherapy regimens without Irinotecan No hepatic, renal and hematopoietic dysfunction; no hemorrhage of digestive tract,obstructive jaundice, gastrointestinal perforation or obstruction ECOG PS:0-2 Expected OS ≥ 3 months Exclusion Criteria: obstruction of digestive tract, thrombosis or other intolerant side effects during treatment

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (thalidomide+CPT-11)<br>Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles ,and oral thalidomide 100 mg/d qn. Maintenance therapy with thalidomide in the same dose is performed until disease progression. | Drug: Thalidomide<br>* Given orally<br>* Other names: Thalomid;Drug: CPT-11<br>* Given Ivgtt<br>* Other names: U-101440E;|
| Experimental: Arm B (CPT-11)<br>Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles. | Drug: CPT-11<br>* Given Ivgtt<br>* Other names: U-101440E;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression(TTP) |  | up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate (CRR) for advanced gastric cancer |  | up to 2 months | 
| overall survival (OS) |  | up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thalidomide, Irinotecan, Second Line