BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: ixabepilone
* Drug: Fluoropyrimidine
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-247550<br> | Drug: ixabepilone<br> <br> Drug: Fluoropyrimidine<br> <br> Drug: Irinotecan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum