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

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