A Phase I Study of OSI-7904L In Combination With Oxaliplatin In Patients With Advanced Colo-Rectal Cancer

Date de début de l'étude : 1 février 2004

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