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

NCT00022477 | Completed Phase 2

• 3 other identifiers: 11003BUCCRC-11003BNCI-3670
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 15

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.

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

Outcome Measures

Primary Outcomes (1)

• Response rate of BMS-247550 in colon cancer

  6 weeks

Study Arms (1)

BMS-247550

EXPERIMENTAL

IV administration of BMS-247550 once every 21 days

Drug: BMS-247550

Interventions

BMS-247550 DRUG

Also known as: ixabepilone, Ixempra®

BMS-247550

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

LaGrange Memorial Hospital

LaGrange, Illinois, 60525, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

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

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46885-5099, United States

Location

Michiana Hematology/Oncology P.C.

South Bend, Indiana, 46601, United States

Location

Lakeland Medical Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hedy L. Kindler, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: August 5, 2003
• Study Start: September 1, 2001
• Primary Completion: October 1, 2002
• Study Completion: December 1, 2004
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (15)