Tipifarnib Plus Tamoxifen in Treating Women With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Tamoxifen may fight breast cancer by blocking the use of estrogen. Combining tipifarnib with tamoxifen may be effective treatment for metastatic breast cancer.

PURPOSE: This phase II trial is studying how well giving tipifarnib together with tamoxifen works in treating women with metastatic breast cancer.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Tamoxifen; Tipifarnib

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic (stage IV) breast cancer

• Evidence of disease progression

• Measurable disease

• Must have been previously treated with at least 1 hormonal therapy with either an aromatase inhibitor or an estrogen receptor (ER)-modulating drug in the adjuvant or metastatic setting and meets 1 of the following criteria:

• Hormone-responsive disease:

• Stable disease (no recurrence or progression for at least 6 months)

• Objective response

• Hormone-nonresponsive disease:

• No stable disease

• No objective response

• Previously treated CNS disease allowed provided patient has a life expectancy of at least 3 months (phase I patients) (Phase I closed to accrual effective 10/23/2003)

• No CNS metastases (phase II patients)

• Hormone receptor status:

• ER and/or progesterone receptor positive

• NOTE: As few as 1% positive cells considered positive

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• See Disease Characteristics

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

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

Hepatic

• Bilirubin no greater than 2.0 mg/dL (unless evidence of Gilbert's disease)

• SGOT and SGPT less than 3 times upper limit of normal (unless liver involvement by tumor)

Renal

• Creatinine no greater than 1.5 mg/dL

Other

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective nonhormonal contraception during and for 2 months after study participation

• No medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No more than 2 prior chemotherapy regimens for metastatic disease (phase II patients)

• No limitations on prior neoadjuvant or adjuvant regimens

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• See Disease Characteristics

• At least 6 months since prior tamoxifen

• Concurrent stable dose of steroids allowed (phase I patients) (Phase I closed to accrual effective 10/23/2003)

Radiotherapy

• No concurrent radiotherapy

Surgery

• Concurrent surgery allowed provided the need for surgery is not due to disease progression

Other

• Recovered from all prior therapy

• No prior warfarin

• No concurrent cytochrome p450-inducing anti-convulsants

• No other concurrent anticancer therapies

• Concurrent bisphosphonates for bone metastases allowed