Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer
Eligibility 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
Sites / Locations
- University of Miami Sylvester Comprehensive Cancer Center