Irinotecan as 3rd Line Therapy in Gastric Cancer

Phase 2

• Conditions: Stomach Neoplasms
• Interventions: Drug: Irinotecan

• Registration Number: NCT02662959
• Lead Sponsor: Fudan University

Brief Summary

Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable or metastatic disease at the time of diagnosis. Systemic therapy was required for the patients with advanced stage. Platinum combined with fluoropyrimidines always were considered as first line treatment. After failure of initial therapy, single agent of taxanes was used as second line treatment. However, there is no relative standard chemotherapeutic regimen in the third therapy except oral anti-angiogenesis drug-Apatinib. So this study was designed to explore the role of single agent with irinotecan as third line treatment in patients with metastatic gastric cancer in China.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-23
• Status Verified: 2015-11
• Study First Submitted QC: 2016-01-21
• Last Update Submitted: 2016-01-21
• Study First Posted: 2016-01-26
• Last Update Posted: 2016-01-26
• Primary Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
• Have failed for 2 lines of chemotherapy
• Life expectancy of more than 3 months
• ECOG performance scale ≤ 2
• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
• Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
• More than 4 weeks for operation or radiotherapy
• More than 4 weeks for cytotoxic agents or growth inhibitors
• Adequate hepatic, renal, heart, and hematologic functions (platelets > 100 × 109/L, neutrophil > 1.5× 109/L, serum creatinine ≤ 1×upper limit of normal(ULN), total bilirubin within 1× ULN, and serum transaminase≤2.5×the ULN).
• Exclusion of pregnant or lactating women

Exclusion Criteria

• Previously receiving irinotecan treatment
• Participated other clinical trials within 4 weeks
• Known Gilbert Syndrome or other biliary tract obstructive disease
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Evidence of CNS metastasis
• Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
• Receiving the therapy of thrombolysis or anticoagulation
• Disability of serious uncontrolled intercurrence infection.
• Uncontrolled pleural effusion and ascites

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irinotecan	Irinotecan	In the experimental arm, patients receive single agent of irinotecan as third line treatment in metastatic gastric cancer.

Primary Outcome Measures

Name	Time	Method
Overall Survival	1 year	From the day enrolled in the study to death

Secondary Outcome Measures

Name	Time	Method
Progression free survival	6 month
Objective Response Rate	8 weeks	evaluated by RECIST 1.1
Number of Adverse Events	Participants will be followed for the duration of treatment interval, an expected average of two weeks

Trial Locations

Locations (1)

Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China