Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wang Jufeng
• Collaborators: Henan Provincial Hospital; Henan Provincial People's Hospital; Second Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Henan University of Science and Technology; The First Affiliated Hospital of Zhengzhou University
• Treatments: Camptothecin; Irinotecan; Thalidomide

Criteria

Inclusion Criteria:

• 18y- 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