Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer
Colorecal Neoplasms - Secondary
Conditions: official terms
Colorectal Neoplasms
Conditions: Keywords
colorectal neoplasms, secondary, Combination chemotherapy, S-1, irinotecan, oxaliplatin
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: S-1, irinotecan, oxaliplatin
Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
National Cancer Center Korea
Goyang, Gyeonggi, Korea, Republic of
Status: Recruiting
Contact: Kyung Hae Jung, M.D.Ph.D - +82-31-920-1611 -
Start Date
July 2007
Completion Date
June 2010
National Cancer Center, Korea
National Cancer Center, Korea
Record processing date processed this data on July 28, 2015 page