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

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Thalidomide

CPT-11

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Thalidomide, Irinotecan, Second Line

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A (thalidomide+CPT-11)

Arm B (CPT-11)

Arm Description

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.

Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles.

Outcomes

Primary Outcome Measures

time to progression(TTP)

Secondary Outcome Measures

complete response rate (CRR) for advanced gastric cancer

overall survival (OS)

Full Information

NCT ID

NCT02401971

First Posted

February 25, 2015

Last Updated

March 27, 2015

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

1. Study Identification

Unique Protocol Identification Number

NCT02401971

Brief Title

Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer

Acronym

ITAGC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

August 2014 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wang Jufeng

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Thalidomide, Irinotecan, Second Line

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A (thalidomide+CPT-11)

Arm Type

Experimental

Arm Description

Arm Title

Arm B (CPT-11)

Arm Type

Experimental

Arm Description

Patients will receive CPT-11 180 mg/m^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles.

Intervention Type

Drug

Intervention Name(s)

Thalidomide

Other Intervention Name(s)

Kevadon, Synovir, THAL, Thalomid

Intervention Description

Given orally

Intervention Type

Drug

Intervention Name(s)

CPT-11

Other Intervention Name(s)

Irinotecan hydrochloride, Campto, Camptosar, irinotecan, U-101440E

Intervention Description

Given Ivgtt

Primary Outcome Measure Information:

Title

time to progression(TTP)

Time Frame

up to 2 months

Secondary Outcome Measure Information:

Title

complete response rate (CRR) for advanced gastric cancer

Time Frame

up to 2 months

Title

overall survival (OS)

Time Frame

up to 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wang Jufeng

Phone

13783583966

13783583966@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wang Jufeng

Organizational Affiliation

Henan Cancer Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Qin Yanru

Organizational Affiliation

The First Affiliated Hospital of Zhengzhou University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zhou Yun

Organizational Affiliation

Henan Provincial People's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zhang Zhongmian

Organizational Affiliation

Second Affiliated Hospital of Zhengzhou University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Guo Yanzhen

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henan Cancer Hospital

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wang Jufeng

Phone

13783583966@163.com

12. IPD Sharing Statement

Learn more about this trial

Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer

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