BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic colorectal adenocarcinoma Prior treatment for metastatic disease with at least: One regimen of irinotecan in combination with a fluoropyrimidine OR Two regimens comprising fluoropyrimidine-based first-line therapy and irinotecan-based second-line therapy May have received cetuximab and/or a fluoropyrimidine as part of second- line therapy Disease progression during or within 4 months of treatment with irinotecan At least 1 bidimensionally measurable lesion No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm^3 Platelet count greater than 125,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known prior severe hypersensitivity reactions to agents containing Cremophor EL No motor or sensory neuropathy grade 2 or greater No concurrent serious uncontrolled infection or other nonmalignant medical illness No concurrent psychiatric disorders or other conditions that would preclude study compliance No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent immunotherapy No growth factors for 24 hours before and after cytotoxic chemotherapy Chemotherapy: See Disease Characteristics Additional prior adjuvant or neoadjuvant chemotherapy allowed At least 4 weeks since prior chemotherapy and recovered No more than 2 prior regimens of cytotoxic chemotherapy for metastatic disease No prior oxaliplatin No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except hormone replacement therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to target lesion unless the lesion has shown progression after completion of radiotherapy No concurrent therapeutic radiotherapy Focal radiotherapy for palliation of bone symptoms may be allowed Surgery: At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered Other: No other concurrent experimental anticancer medications
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Georgia Cancer Specialists
Arms of the Study
Arm 1
Experimental
BMS-247550