OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer Radiologic evidence of advanced disease At least 1 measurable lesion at least 20 mm OR at least 10 mm by spiral CT scan Indicator lesions in a previously irradiated field are allowed provided the irradiated lesion has clearly progressed OR a new lesion has developed in the irradiated field Failed 1, and only 1, line of prior chemotherapy for advanced/metastatic disease Disease progression during chemotherapy OR within 6 months after completion of treatment No symptomatic brain metastases meeting any of the following criteria: Unstable Inadequately controlled with fixed-dose oral steroids Potentially life-threatening Required radiotherapy with the past 28 days PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Bilirubin < 1.5 times ULN No hepatitis No cirrhosis Renal Creatinine < 1.5 times ULN Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation HIV negative No preexisting neuropathy ≥ grade 2 No active or uncontrolled infection No other serious illness or medical condition No chronic alcohol abuse No known hypersensitivity to systemic liposomal formulations or compounds chemically related to OSI-7904L or oxaliplatin No prior psychiatric or neurologic condition that would preclude study compliance or giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy At least 21 days since prior immunotherapy At least 21 days since prior monoclonal antibody therapy Chemotherapy See Disease Characteristics At least 21 days since prior chemotherapy and recovered* No prior oxaliplatin NOTE: *Alopecia allowed Endocrine therapy See Disease Characteristics At least 21 days since prior hormonal therapy Radiotherapy See Disease Characteristics At least 21 days since prior radiotherapy and recovered No prior radiotherapy to more than 25% of bone marrow reserve Surgery Recovered from prior surgery Other At least 21 days since prior tyrosine kinase inhibitor therapy More than 21 days since prior investigational agents No other concurrent anticancer therapy No other concurrent investigational agents
Sites / Locations
- Medizinische Hochschule Hannover
- Christie Hospital N.H.S. Trust