ITAGC: Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer

Sponsor

Wang Jufeng (Other)

Overall Status

Unknown status

CT.gov ID

NCT02401971

Collaborator

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

900

Enrollment

Location

Arms

Duration (Months)

18.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: Thalidomide Drug: CPT-11	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

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

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 hydrochloride

Campto

Camptosar

irinotecan

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 hydrochloride

Campto

Camptosar

irinotecan

U-101440E

Outcome Measures

Primary Outcome Measures

time to progression(TTP) [up to 2 months]

Secondary Outcome Measures

complete response rate (CRR) for advanced gastric cancer [up to 2 months]
overall survival (OS) [up to 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henan Cancer Hospital	Zhengzhou	Henan	China	450000

Sponsors and Collaborators

Wang Jufeng
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