bms-247550 in treating patients with recurrent or metastatic colorectal cancer

Conditions: Colorectal Cancer

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.

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.

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

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum