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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00022477
Enrollment
24
Registered
2003-08-05
Start date
2001-09-30
Completion date
2004-12-31
Last updated
2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Chicago
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Response rate of BMS-247550 in colon cancer6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026