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

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 recurrent or metastatic colorectal cancer.

OBJECTIVES:

* Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with BMS-247550.
* Determine the toxicity of this drug in these patients.
* Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 8-10 months.

Eligibility Criteria:
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