BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center; R-Pharm
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed breast cancer

• Metastatic disease by radiography or histology

• Must have received prior chemotherapy with a taxane and an anthracycline in the adjuvant or metastatic setting

• No more than 2 prior chemotherapy regimens in the metastatic setting

• Measurable or evaluable disease

• Bone lesions not measurable

• Primary breast lesions not measurable if assessed only by physical exam

• No active brain metastasis

• No cerebral edema by CT scan or MRI

• No progression since prior imaging studies

• No requirement for steroids

• No clinical symptoms of brain metastasis

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Not specified

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9.0 g/dL

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• ALT no greater than 2.5 times ULN

Renal

• Creatinine less than 1.5 times ULN

Cardiovascular

• No uncontrolled or significant cardiovascular disease

• No myocardial infarction within the past year

• No uncontrolled angina within the past year

• No history of congestive heart failure

• No history of atrial or ventricular arrhythmias

• No history of second- or third-degree heart block

• No uncontrolled hypertension

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No hypersensitivity to Cremophor EL or fluorouracil

• No prior intolerance to fluoropyrimidines

• No other serious uncontrolled medical disorder or active infection that would preclude study

• No dementia or altered mental status that would preclude study

• No grade 2 or greater neuropathy (neuromotor or neurosensory)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Chemotherapy

• Prior immunotherapy allowed

• No concurrent trastuzumab (Herceptin)

• No concurrent immunotherapy

Chemotherapy

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome)

• At least 2 years since prior high-dose chemotherapy with bone marrow transplantation or peripheral blood stem cell support

• No prior epothilone, capecitabine, or continuous-infusion fluorouracil

• No other concurrent chemotherapy

Endocrine therapy

• Prior hormonal therapy allowed

• No concurrent hormonal therapy

• Concurrent hormone replacement therapy allowed

Radiotherapy

• At least 3 weeks since prior radiotherapy

• No prior radiotherapy to more than 25% of the bone marrow

• No concurrent therapeutic radiotherapy

Surgery

• Not specified

Other

• At least 3 weeks since prior investigational cytotoxic agents

• No concurrent warfarin for therapeutic anticoagulation

• Low-dose warfarin allowed for implanted ports or indwelling catheters

• No other concurrent experimental anticancer medications

• No other concurrent antitumor therapy

• Concurrent bisphosphonates for palliation of bone metastases allowed if initiated before study