bms-247550 in treating patients with 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 metastatic colorectal cancer.

objectives: * determine the clinical activity of bms-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan. * determine the safety of this drug in these patients. * determine the response duration, time to progression, and survival in patients treated with this drug. outline: this is a multicenter study. patients receive bms-247550 iv over 1 hour on days 1-5. treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. patients achieving a complete response (cr) receive up to 4 additional courses of treatment beyond cr. patients are followed every 3 months. projected accrual: a total of 19-55 patients will be accrued for this study within 6 months.

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

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