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BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
Fluoropyrimidine
Irinotecan
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Georgia Cancer Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMS-247550

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determine the safety of this drug in these patients.
Determine the response duration, time to progression, and survival in patients treated with this drug.

Full Information

First Posted
April 9, 2002
Last Updated
August 1, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00033306
Brief Title
BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
Official Title
A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Study Start Date
February 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-247550
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ixabepilone
Intervention Type
Drug
Intervention Name(s)
Fluoropyrimidine
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Primary Outcome Measure Information:
Title
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.
Time Frame
baseline to survival
Secondary Outcome Measure Information:
Title
Determine the safety of this drug in these patients.
Time Frame
baseline to survival
Title
Determine the response duration, time to progression, and survival in patients treated with this drug.
Time Frame
baseline to survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Forero-Torres, MD, CSU
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Georgia Cancer Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

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BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

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