Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer

Gastric Cancer Clinical Trial

— ITAGC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02401971
• Other study ID #: DREAM-002
• Status: Recruiting
• Phase: Phase 4
• First received: February 25, 2015
• Last updated: March 27, 2015
• Start date: August 2014
• Est. completion date: August 2018

Study information

• Verified date: September 2014
• Source: Zhengzhou University
• Contact: Wang Jufeng
• Phone: 13783583966
• Email: 13783583966[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: August 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Thalidomide
Given orally
• CPT-11
Given Ivgtt

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (5)

Lead Sponsor	Collaborator
Wang Jufeng	Henan Provincial 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression(TTP)		up to 2 months	No
Secondary	complete response rate (CRR) for advanced gastric cancer		up to 2 months	No
Secondary	overall survival (OS)		up to 2 months	No