BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00033306
First received: April 9, 2002
Last updated: August 1, 2013
Last verified: August 2013
  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
Drug: Fluoropyrimidine
Drug: Irinotecan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

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. [ Time Frame: baseline to survival ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the safety of this drug in these patients. [ Time Frame: baseline to survival ] [ Designated as safety issue: Yes ]
  • Determine the response duration, time to progression, and survival in patients treated with this drug. [ Time Frame: baseline to survival ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: February 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-247550 Drug: ixabepilone Drug: Fluoropyrimidine Drug: Irinotecan

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Alabama at Birmingham
Investigators
Study Chair: Andres Forero-Torres, MD, CSU University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00033306     History of Changes
Other Study ID Numbers: CDR0000069272, UAB-0145, BMS-CA163-012, UAB-F011029021, NCI-G02-2051
Study First Received: April 9, 2002
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014