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

NCT ID: NCT00022477

Last Updated: 2013-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2004-12-31

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 recurrent or metastatic colorectal cancer.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BMS-247550

IV administration of BMS-247550 once every 21 days

Group Type: EXPERIMENTAL

BMS-247550

Intervention Type: DRUG

Interventions

BMS-247550

Intervention Type: DRUG

Other Intervention Names

ixabepilone, Ixempra®

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hedy L. Kindler, MD

Role: STUDY_CHAIR

University of Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Louis A. Weiss Memorial Hospital

Chicago, Illinois, United States

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Evanston Northwestern Health Care

Evanston, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

LaGrange Memorial Hospital

LaGrange, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Lutheran General Cancer Care Center

Park Ridge, Illinois, United States

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, United States

Central Illinois Hematology Oncology Center

Springfield, Illinois, United States

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, United States

Michiana Hematology/Oncology P.C.

South Bend, Indiana, United States

Lakeland Medical Center - St. Joseph

Saint Joseph, Michigan, United States

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

UCCRC-11003B

Identifier Type: -

Identifier Source: secondary_id

NCI-3670

Identifier Type: -

Identifier Source: secondary_id

11003B

Identifier Type: -

Identifier Source: org_study_id