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

Inclusion Criteria

• •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