Capecitabine and Oxaliplatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven unresectable, advanced or metastatic colorectal cancer Measurable disease Phase I: Any pretreatment status Phase II-N (chemotherapy naive patients): No prior chemotherapy for advanced or metastatic cancer and no prior adjuvant chemotherapy OR No prior chemotherapy for advanced or metastatic cancer and prior adjuvant chemotherapy ended more than 6 months ago Phase II-P (thymidylate synthase inhibitor pretreated patients): No thymidylate synthase inhibitor based regimen for advanced or metastatic cancer and prior adjuvant chemotherapy ended less than 6 months ago OR One thymidylate synthase inhibitor based regimen for advanced or metastatic cancer and no adjuvant thymidylate synthase inhibitor based regimen OR One thymidylate synthase inhibitor based regimen for advanced or metastatic cancer and one additional adjuvant thymidylate synthase inhibitor based regimen ended more than 6 months ago No CNS metastases PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: 0 or 1 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2 times ULN (5 times ULN if related to liver metastases) Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No congestive heart failure No symptomatic coronary artery disease No cardiac arrhythmia unless well controlled with medication No myocardial infarction within the past 12 months Neurologic: No peripheral neuropathy of any origin worse than grade 1 No prior or concurrent seizures or CNS disorder requiring treatment Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No dysphagia, malabsorption, or intestinal obstruction that could impact the absorption or excretion of study drug No psychiatric disability precluding informed consent or compliance No prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanomatous skin cancer No other significant medical condition PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 4 weeks since prior major gastrointestinal surgery
Sites / Locations
- Inselspital, Bern