Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced Breast Cancer
Inflammatory Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
About this trial
This is an interventional treatment trial for Inflammatory Breast Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the breast Phase I (closed to accrual as of 1/19/04): Nonregional stage IV disease Phase II: Locally advanced disease, according to AJCC staging criteria: Stage IIB Stage IIIA Stage IIIB Stage IIIC At least 1 bidimensionally or unidimensionally measurable indicator lesion Hormone receptor status: Not specified Female Performance status - ECOG 0-1 Performance status - Karnofsky 70-100% Not specified WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Creatinine normal Creatinine clearance at least 60 mL/min LVEF normal No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No other invasive malignancies within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No prior allergic reactions attributed to compounds of similar chemical or biological composition to tipifarnib or other agents used in the study (e.g., imidazoles or quinolones) No ongoing or active infection No other concurrent uncontrolled illness that would preclude study participation No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Not specified Phase I (closed to accrual as of 1/19/04): More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No more than 1 prior adjuvant/neoadjuvant regimen and 1 prior regimen for metastatic disease Prior doxorubicin allowed provided the following are true: Used in adjuvant setting Cumulative dose was no greater than 240 mg/m^2 At least 1 year between completion of adjuvant therapy and relapse Phase II: No prior chemotherapy for locally advanced breast cancer At least 1 week since prior tamoxifen or other selective estrogen receptor modulators for prevention or other indications (e.g., osteoporosis, ductal carcinoma in situ, or invasive breast cancer) Phase I (closed to accrual as of 1/19/04): More than 4 weeks since prior radiotherapy Phase II: No prior radiotherapy for locally advanced breast cancer Not specified No antacids within 2 hours of study drug administration No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent anticancer therapy No other concurrent investigational agents
Sites / Locations
- Albert Einstein College of Medicine
Arms of the Study
Arm 1
Experimental
Treatment (doxorubicin, cyclophosphamide, tipifarnib, G-CSF)
PHASE I (nonregional stage IV disease) (closed to accrual as of 1/19/04): Patients receive doxorubicin IV over 10-15 minutes and cyclophosphamide IV over 30 minutes on day 1, oral tipifarnib twice daily on days 2-7, and G-CSF subcutaneously on days 2-13. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. PHASE II (stage IIB, IIIA, IIIB, or IIIC): Patients receive tipifarnib at the MTD and doxorubicin, cyclophosphamide, and G-CSF as in phase I (phase I closed to accrual as of 1/19/04). After the fourth course, patients may undergo complete resection.