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BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00033306
Enrollment
2
Registered
2003-08-06
Start date
2002-02-28
Completion date
2005-07-31
Last updated
2013-08-05

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 metastatic colorectal cancer.

Detailed description

OBJECTIVES: * Determine the clinical activity of BMS-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan. * Determine the safety of this drug in these patients. * Determine the response duration, time to progression, and survival in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive up to 4 additional courses of treatment beyond CR. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 19-55 patients will be accrued for this study within 6 months.

Interventions

DRUGixabepilone
DRUGIrinotecan

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Alabama at Birmingham
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 colorectal adenocarcinoma * Prior treatment for metastatic disease with at least: * One regimen of irinotecan in combination with a fluoropyrimidine OR * Two regimens comprising fluoropyrimidine-based first-line therapy and irinotecan-based second-line therapy * May have received cetuximab and/or a fluoropyrimidine as part of second- line therapy * Disease progression during or within 4 months of treatment with irinotecan * At least 1 bidimensionally measurable lesion * No known CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count greater than 125,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present) Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No New York Heart Association class III or IV heart disease * No history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known prior severe hypersensitivity reactions to agents containing Cremophor EL * No motor or sensory neuropathy grade 2 or greater * No concurrent serious uncontrolled infection or other nonmalignant medical illness * No concurrent psychiatric disorders or other conditions that would preclude study compliance * No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No concurrent immunotherapy * No growth factors for 24 hours before and after cytotoxic chemotherapy Chemotherapy: * See Disease Characteristics * Additional prior adjuvant or neoadjuvant chemotherapy allowed * At least 4 weeks since prior chemotherapy and recovered * No more than 2 prior regimens of cytotoxic chemotherapy for metastatic disease * No prior oxaliplatin * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except hormone replacement therapy Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered * No prior radiotherapy to target lesion unless the lesion has shown progression after completion of radiotherapy * No concurrent therapeutic radiotherapy * Focal radiotherapy for palliation of bone symptoms may be allowed Surgery: * At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered Other: * No other concurrent experimental anticancer medications

Design outcomes

Primary

MeasureTime frame
Determine the clinical activity of BMS-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan.baseline to survival

Secondary

MeasureTime frame
Determine the safety of this drug in these patients.baseline to survival
Determine the response duration, time to progression, and survival in patients treated with this drug.baseline to survival

Countries

United States

Outcome results

None listed

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