Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer (ITAGC)

March 27, 2015 updated by: Wang Jufeng

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (thalidomide+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.
Drug: Thalidomide
Given orally
Other Names:
  • Kevadon
  • Synovir
  • THAL
  • Thalomid
Drug: CPT-11
Given Ivgtt
Other Names:
  • irinotecan
  • Irinotecan hydrochloride
  • Campto
  • Camptosar
  • U-101440E
Experimental: Arm B (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.
Drug: CPT-11
Given Ivgtt
Other Names:
  • irinotecan
  • Irinotecan hydrochloride
  • Campto
  • Camptosar
  • U-101440E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to progression(TTP)
Time Frame: up to 2 months
up to 2 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wang Jufeng

Collaborators

The First Affiliated Hospital of Zhengzhou University
Henan Provincial People's Hospital
Second Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Henan University of Science and Technology

Investigators

  • Study Chair: Wang Jufeng, Henan Cancer Hospital
  • Principal Investigator: Qin Yanru, The First Affiliated Hospital of Zhengzhou University
  • Principal Investigator: Zhou Yun, HeNan Provincial People's Hospital
  • Principal Investigator: Zhang Zhongmian, Second Affiliated Hospital of Zhengzhou University
  • Principal Investigator: Guo Yanzhen, The First Affiliated Hospital of Henan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 27, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DREAM-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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