BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00022477
First received: August 10, 2001
Last updated: September 4, 2013
Last verified: September 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 recurrent or metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: BMS-247550
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Advanced Colorectal Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Response rate of BMS-247550 in colon cancer [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2001
Study Completion Date: December 2004
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-247550
IV administration of BMS-247550 once every 21 days
Drug: BMS-247550
Other Name: ixabepilone, Ixempra®

Detailed Description:

OBJECTIVES:

  • Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with BMS-247550.
  • Determine the toxicity of this drug in these patients.
  • Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 8-10 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 or locally recurrent adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • The following are not considered measurable lesions:

      • Lesions seen on colonoscopic examination or barium study
      • Bone metastases
      • CNS lesions
      • Ascites
  • Failed prior combination therapy comprising fluorouracil, leucovorin calcium, and irinotecan for metastatic disease
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • ALT/AST no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No grade 2 or greater peripheral neuropathy
  • No history of allergic hypersensitivity reaction to compounds containing polyoxyethylated castor oil (Cremophor EL) (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550)
  • No other currently active malignancy (less than 30% risk of relapse and completed prior therapy) except non-melanoma skin cancer or carcinoma in situ of the cervix
  • No uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy
  • No concurrent colony-stimulating factors during first course of therapy

Chemotherapy:

  • See Disease Characteristics
  • Prior adjuvant chemotherapy allowed
  • At least 4 weeks since prior cytotoxic chemotherapy and recovered
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent therapeutic radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior surgery

Other:

  • At least 30 days since prior investigational agents
  • At least 7 days since prior cimetidine
  • No other concurrent anticancer investigational agents, commercial agents, or therapies
  • No concurrent unconventional therapy, food, or vitamin supplement containing Hypericum perforatum (St. John's Wort)
  • No concurrent cimetidine
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  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: NCT00022477

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
LaGrange Memorial Hospital
LaGrange, Illinois, United States, 60525
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46885-5099
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States, 46601
United States, Michigan
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Hedy L. Kindler, MD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00022477     History of Changes
Other Study ID Numbers: 11003B, UCCRC-11003B, NCI-3670
Study First Received: August 10, 2001
Last Updated: September 4, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Chicago:
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

ClinicalTrials.gov processed this record on August 27, 2014