A Phase II Trial Of Tipifarnib (R15777, ZARNESTRA) In Combination With Tamoxifen In Subjects With Metastatic Breast Cancer
- Determine the maximum tolerated dose and recommended phase II dose of tipifarnib
administered with tamoxifen in women with hormone receptor-positive metastatic breast
cancer (Phase I closed to accrual effective 10/23/2003).
- Determine the acute and chronic toxicity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the response rate and time to progression in patients treated with this
OUTLINE: This is an open-label study of tipifarnib (Phase I closed to accrual effective
10/23/2003). Patients are stratified according to benefit from prior hormonal therapy (yes
vs no) (phase II).
- Phase I (closed to accrual effective 10/23/2003): Patients receive oral tipifarnib
twice daily on days 1-21. Patients also receive oral tamoxifen daily on days 8-18
(during course I only) and on days 1-28 during all subsequent courses. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Once the MTD is determined, additional patients are accrued and treated at
that dose level in the phase II portion of the study.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 9-12 patients will be accrued for the phase I portion of this
study (Phase I closed to accrual effective 10/23/2003). A total of 27-40 patients will be
accrued for the phase II portion of this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
JoAnne Zujewski, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|