Irinotecan as 3rd Line Therapy in Gastric Cancer

NCT ID: NCT02662959

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30

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.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Irinotecan

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

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

180 mg/m2, IV (in the vein) on day 1 of each 14 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Interventions

Irinotecan

180 mg/m2, IV (in the vein) on day 1 of each 14 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Weijian Guo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

ZHIYU CHEN, M.D.

Role: CONTACT

zychan75@163.com

+862164175590

Facility Contacts

Zhiyu Chen, MD

Role: primary

References

Yu N, Huang S, Zhang Z, Huang M, Wang Y, Zhang W, Zhang X, Zhu X, Sheng X, Yu K, Chen Z, Guo W. A prospective phase II single-arm study and predictive factor analysis of irinotecan as third-line treatment in patients with metastatic gastric cancer. Ther Adv Med Oncol. 2024 Feb 28;16:17588359241229433. doi: 10.1177/17588359241229433. eCollection 2024.

Reference Type: DERIVED

PMID: 38425987 (View on PubMed)

Other Identifiers

Med Onc-G 01

Identifier Type: -

Identifier Source: org_study_id