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

Wang Jufeng

Status and phase: Unknown; Phase 4

Conditions: Gastric Cancer

Treatments: Drug: CPT-11; Drug: Thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02401971

DREAM-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Arm A (thalidomide+CPT-11)

Experimental group

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.

Treatment:

Drug: Thalidomide

Drug: CPT-11

Arm B (CPT-11)

Experimental group

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.

Treatment:

Drug: CPT-11