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| ID | Type | Description | Link |
|---|---|---|---|
| UAB-0145 | |||
| BMS-CA163-012 | |||
| UAB-F011029021 | |||
| NCI-G02-2051 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-247550 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ixabepilone | Drug |
| ||
| Fluoropyrimidine |
| 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 |
| 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 |
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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
Disease progression during or within 4 months of treatment with irinotecan
At least 1 bidimensionally measurable lesion
No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine 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
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Forero-Torres, MD, CSU | University of Alabama at Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| Irinotecan | Drug |
|
| Georgia Cancer Specialists |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |