BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed metastatic or locally recurrent adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection

At least 1 unidimensionally measurable lesion

At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

The following are not considered measurable lesions:

Lesions seen on colonoscopic examination or barium study
Bone metastases
CNS lesions
Ascites
Failed prior combination therapy comprising fluorouracil, leucovorin calcium, and irinotecan for metastatic disease
No brain metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

At least 3 months

Hematopoietic:

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 mg/dL
ALT/AST no greater than 2.5 times upper limit of normal

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Cardiovascular:

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No grade 2 or greater peripheral neuropathy
No history of allergic hypersensitivity reaction to compounds containing polyoxyethylated castor oil (Cremophor EL) (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550)
No other currently active malignancy (less than 30% risk of relapse and completed prior therapy) except non-melanoma skin cancer or carcinoma in situ of the cervix
No uncontrolled illness
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent immunotherapy
No concurrent colony-stimulating factors during first course of therapy

Chemotherapy:

See Disease Characteristics
Prior adjuvant chemotherapy allowed
At least 4 weeks since prior cytotoxic chemotherapy and recovered
No more than 1 prior chemotherapy regimen for metastatic disease
No other concurrent chemotherapy

Endocrine therapy:

No concurrent anticancer hormonal therapy

Radiotherapy:

At least 4 weeks since prior radiotherapy and recovered
No concurrent therapeutic radiotherapy

Surgery:

See Disease Characteristics
At least 4 weeks since prior surgery

Other:

At least 30 days since prior investigational agents
At least 7 days since prior cimetidine
No other concurrent anticancer investigational agents, commercial agents, or therapies
No concurrent unconventional therapy, food, or vitamin supplement containing Hypericum perforatum (St. John's Wort)
No concurrent cimetidine
No concurrent combination antiretroviral therapy for HIV-positive patients