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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate of BMS-247550 in colon cancer

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

11003B

NCT ID:

NCT00022477

Start Date:

September 2001

Completion Date:

December 2004

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
University of Chicago Cancer Research CenterChicago, Illinois  60637
Loyola University Medical CenterMaywood, Illinois  60153
Ingalls Memorial HospitalHarvey, Illinois  60426
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Evanston Northwestern Health CareEvanston, Illinois  60201
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
University of Illinois at ChicagoChicago, Illinois  60612
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc.Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C.South Bend, Indiana  46617
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
LaGrange Memorial HospitalLaGrange, Illinois  60525