BMS-247550 in Treating Patients With Recurrent or 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 or locally recurrent adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan The following are not considered measurable lesions: Lesions seen on colonoscopic examination or barium study Bone metastases CNS lesions Ascites Failed prior combination therapy comprising fluorouracil, leucovorin calcium, and irinotecan for metastatic disease No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT/AST no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No grade 2 or greater peripheral neuropathy No history of allergic hypersensitivity reaction to compounds containing polyoxyethylated castor oil (Cremophor EL) (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550) No other currently active malignancy (less than 30% risk of relapse and completed prior therapy) except non-melanoma skin cancer or carcinoma in situ of the cervix No uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent colony-stimulating factors during first course of therapy Chemotherapy: See Disease Characteristics Prior adjuvant chemotherapy allowed At least 4 weeks since prior cytotoxic chemotherapy and recovered No more than 1 prior chemotherapy regimen for metastatic disease No other concurrent chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent therapeutic radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery Other: At least 30 days since prior investigational agents At least 7 days since prior cimetidine No other concurrent anticancer investigational agents, commercial agents, or therapies No concurrent unconventional therapy, food, or vitamin supplement containing Hypericum perforatum (St. John's Wort) No concurrent cimetidine No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- University of Illinois at Chicago
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Evanston Northwestern Health Care
- Ingalls Memorial Hospital
- LaGrange Memorial Hospital
- Loyola University Medical Center
- Lutheran General Cancer Care Center
- Oncology/Hematology Associates of Central Illinois, P.C.
- Central Illinois Hematology Oncology Center
- Fort Wayne Medical Oncology and Hematology, Inc.
- Michiana Hematology/Oncology P.C.
- Lakeland Medical Center - St. Joseph
- Albert Einstein Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
BMS-247550
IV administration of BMS-247550 once every 21 days