Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed adenocarcinoma of the colon
• * Metastatic or recurrent disease
• * Redocumentation of tumor histology or cytology prior to protocol therapy is not required if documented tumor was confirmed prior to initial therapy
• Measurable disease
• * Lesion of ≥ 1 cm in longest diameter that can be repetitively assessed by radiographic measurement or any lesion of ≥ 2 cm in longest diameter that can be repetitively assessed by physical examination
• * Positive bone scans, osteoblastic or osteolytic bone lesions, pleural effusions, and positive bone marrow biopsies are not considered measurable or evaluable lesions
• Metastatic disease to the brain allowed if emergent radiotherapy for symptomatic CNS disease is not required
• Must have received at least one prior chemotherapy regimen (with or without radiotherapy)
• * One of the prior regimens must include irinotecan hydrochloride, fluorouracil, and leucovorin calcium or irinotecan hydrochloride and other fluoropyrimidine
• * Previous therapy with C-225 and/or bevacizumab is allowed
• .
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-2
• Granulocyte count ≥1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Creatinine ≤ 2.0 mg/dL
• Bilirubin \< 1.5 mg/dL
• SGOT ≤ 2 times upper limit of normal (ULN)
• Alkaline phosphatase \< 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No serious medical or psychiatric illness that would render chemotherapy unsafe
• No concurrent clinically evident malignancy except inactive nonmelanoma skin cancer, low-grade low-stage bladder carcinoma followed off therapy, or lobular neoplasia of the breast
• No clinical AIDS or known positive HIV serology
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Recovered from prior therapy
• No investigational agent for at least 30 days prior to study entry
• No chemotherapy within the past 3 weeks
• No radiotherapy for palliation within the past 2 weeks prior to study entry
• No prior oxaliplatin or gemcitabine hydrochloride
• No concurrent participation in another clinical trial
• No other concurrent anticancer therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy
• No other concurrent investigational drugs