Colorectal Cancer
Conditions
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have recurrent or metastatic colorectal cancer.
Detailed description
OBJECTIVES: * Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with BMS-247550. * Determine the toxicity of this drug in these patients. * Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 8-10 months.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of BMS-247550 in colon cancer | 6 weeks |
Countries
United States