Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed every 2 cycles of chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed unresectable or metastatic colorectal cancer, not amenable to surgery or radiation treatment for curative intent

• At least one unidimensional measurable lesion

• ECOG performance status 0-2.

• No prior chemotherapy in metastatic settings, but adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment

• Adequate major organ functions

• Give written informed consent

Exclusion Criteria:

• Prior systemic chemotherapy for metastatic disease

• Prior treatment with oxaliplatin or irinotecan

• Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration

• Prior surgical treatment of stage IV disease is permitted

• CNS metastases

• Prior history of peripheral neuropathy ≥ NCI CTC grade 1

• Uncontrolled or severe cardiovascular disease

• Serious concurrent infection or nonmalignant illness

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

• Organ allografts requiring immunosuppressive therapy

• Psychiatric disorder or uncontrolled seizure 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.

• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency

• Known hypersensitivity to platinum compounds or any of the components of the study medications

• Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery

• Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug