BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Terminated

CT.gov ID

NCT00033306

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

40.9

Duration (Months)

Patient Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: ixabepilone Drug: Fluoropyrimidine Drug: Irinotecan	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2002

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Jul 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-247550	Drug: ixabepilone Drug: Fluoropyrimidine Drug: Irinotecan

Arm

Intervention/Treatment

Experimental: BMS-247550

Drug: ixabepilone

Drug: Fluoropyrimidine

Drug: Irinotecan

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	Georgia Cancer Specialists	Atlanta	Georgia	United States	30342