Clinical trial NCT02401971: Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer
Official title: Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer : A Multicenter, Randomized, Controlled and Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastric Cancer
Keywords: Thalidomide
Irinotecan
Second Line
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: Henan Provincial People's Hospital
name: Second Affiliated Hospital of Zhengzhou University
name: The First Affiliated Hospital of Henan University of Science and Technology
First posted: 2015-03-30
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: time to progression(TTP)
timeFrame: up to 2 months
Secondary outcomes:
measure: complete response rate (CRR) for advanced gastric cancer
timeFrame: up to 2 months
measure: overall survival (OS)
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Wang Jufeng
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Qin Yanru
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial People's Hospital
name: Zhou Yun
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Zhengzhou University
name: Zhang Zhongmian
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Guo Yanzhen
role: PRINCIPAL_INVESTIGATOR
References: