BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

NCT ID: NCT00033306

Last Updated: 2013-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2005-07-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BMS-247550

Group Type: EXPERIMENTAL

ixabepilone

Intervention Type: DRUG

Fluoropyrimidine

Intervention Type: DRUG

Irinotecan

Intervention Type: DRUG

Interventions

ixabepilone

Intervention Type: DRUG

Fluoropyrimidine

Intervention Type: DRUG

Irinotecan

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andres Forero-Torres, MD, CSU

Role: STUDY_CHAIR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Georgia Cancer Specialists

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

UAB-0145

Identifier Type: -

Identifier Source: secondary_id

BMS-CA163-012

Identifier Type: -

Identifier Source: secondary_id

UAB-F011029021

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2051

Identifier Type: -

Identifier Source: secondary_id

CDR0000069272

Identifier Type: -

Identifier Source: org_study_id