BMS-247550 in Treating Patients With Metastatic Colorectal Cancer

The University of Alabama at Birmingham

Status and phase

Terminated

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Irinotecan

Drug: ixabepilone

Drug: Fluoropyrimidine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00033306

CDR0000069272

NCI-G02-2051

BMS-CA163-012

UAB-0145

UAB-F011029021

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: