Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer

Phase 4

• Conditions: Gastric Cancer
• Interventions: Drug: CPT-11; Drug: Thalidomide

• Registration Number: NCT02401971
• Lead Sponsor: Wang Jufeng

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-08
• Status Verified: 2014-09
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-27
• Last Update Submitted: 2015-03-27
• Study First Posted: 2015-03-30
• Last Update Posted: 2015-03-30
• Primary Completion: 2016-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B (CPT-11)	CPT-11	Patients will receive CPT-11 180 mg/m\^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles.
Arm A (thalidomide+CPT-11)	Thalidomide	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.
Arm A (thalidomide+CPT-11)	CPT-11	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.

Primary Outcome Measures

Name	Time	Method
time to progression(TTP)	up to 2 months

Secondary Outcome Measures

Name	Time	Method
complete response rate (CRR) for advanced gastric cancer	up to 2 months
overall survival (OS)	up to 2 months

Trial Locations

Locations (1)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China