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

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT00022477

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: BMS-247550	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Oct 1, 2002

Actual Study Completion Date :

Dec 1, 2004

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: BMS-247550

IV administration of BMS-247550 once every 21 days

Drug: BMS-247550

Other Names:

ixabepilone, Ixempra®

Outcome Measures

Primary Outcome Measures

Response rate of BMS-247550 in colon cancer [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60612
2	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
3	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
4	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
5	Evanston Northwestern Health Care	Evanston	Illinois	United States	60201
6	Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
7	LaGrange Memorial Hospital	LaGrange	Illinois	United States	60525
8	Loyola University Medical Center	Maywood	Illinois	United States	60153
9	Lutheran General Cancer Care Center	Park Ridge	Illinois	United States	60068
10	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois	United States	61602
11	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62701
12	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana	United States	46885-5099
13	Michiana Hematology/Oncology P.C.	South Bend	Indiana	United States	46601
14	Lakeland Medical Center - St. Joseph	Saint Joseph	Michigan	United States	49085
15	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461