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

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