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

A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Advanced Colorectal Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: BMS-247550

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-247550; IV administration of BMS-247550 once every 21 days	Drug: BMS-247550; Other Names: ixabepilone, Ixempra®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate of BMS-247550 in colon cancer	6 weeks

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): October 1, 2002
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: August 10, 2001
• First Submitted That Met QC Criteria: August 4, 2003
• First Posted (Estimate): August 5, 2003

Study Record Updates

• Last Update Posted (Estimate): September 5, 2013
• Last Update Submitted That Met QC Criteria: September 4, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon; recurrent colon cancer; recurrent rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 11003B; UCCRC-11003B; NCI-3670