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BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033306
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: ixabepilone
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Irinotecan Irinotecan hydrochloride Ixabepilone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033306

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Investigators
Study Chair: Andres Forero-Torres, MD, CSU Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069272, UAB-0145, BMS-CA163-012, UAB-F011029021, NCI-G02-2051
Study First Received: April 9, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00033306  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Epothilones
Irinotecan
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009