A Phase I Study of S-1 Plus Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open-label, single center, and a dose-escalating phase I study to determine the maximal tolerated dose and the recommended dose of S-1 combined with irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric carcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Camptothecin; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed unresectable or metastatic colorectal or gastric carcinoma

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Measurable disease, according to the RECIST criteria or non-measurable disease Measurable lesions

• Previous adjuvant, palliative chemotherapy including 5-FU, oxaliplatin and irinotecan, molecular targeted therapy and/or radiotherapy is allowed

• Adequate major organ functions

• Patients should sign a written informed consent before study entry

Exclusion Criteria:

• Prior history of peripheral neuropathy

• Inadequate cardiovascular

• Serious concurrent infection or nonmalignant illness

• Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix

• Psychiatric disorder that would preclude compliance

• Pregnant, nursing women or patients with reproductive potential without contraception

• Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.