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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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 recurrent or metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: National Cancer Institute (NCI)
• Treatments: Epothilones

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