Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer
Conditions
Colorecal Neoplasms - Secondary
Conditions: official terms
Colorectal Neoplasms
Conditions: Keywords
colorectal neoplasms, secondary, Combination chemotherapy, S-1, irinotecan, oxaliplatin
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1, irinotecan, oxaliplatin
Type: Drug
Overall Status
Recruiting
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.
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
Location
National Cancer Center Korea
Goyang, Gyeonggi, Korea, Republic of
Status: Recruiting
Contact: Kyung Hae Jung, M.D.Ph.D - +82-31-920-1611 - khjung@ncc.re.kr
Start Date
July 2007
Completion Date
June 2010
Sponsors
National Cancer Center, Korea
Source
National Cancer Center, Korea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page