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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022477
• Other study ID #: 11003B
• Secondary ID: UCCRC-11003BNCI-
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2001
• Last updated: September 4, 2013
• Start date: September 2001
• Est. completion date: December 2004

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2004
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• BMS-247550

Locations

Country	Name	City	State
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
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	Lakeland Medical Center - St. Joseph	Saint Joseph	Michigan
United States	Michiana Hematology/Oncology P.C.	South Bend	Indiana
United States	Central Illinois Hematology Oncology Center	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of BMS-247550 in colon cancer		6 weeks	No