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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
- 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
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