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 metastatic colorectal cancer.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | baseline to survival |
Secondary
| Measure | Time frame |
|---|---|
| Determine the safety of this drug in these patients. | baseline to survival |
| Determine the response duration, time to progression, and survival in patients treated with this drug. | baseline to survival |
Countries
United States