Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer (TIROX2)

National Cancer Center (NCC)

Status and phase

Unknown

Phase 2

Conditions

Secondary

Colorecal Neoplasms

Treatments

Drug: S-1, irinotecan, oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00506571

NCCCTS-07-261

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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