Overview

Tipifarnib and Combination Chemotherapy in Treating Patients With Stage II or Stage III Breast Cancer

Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
Summary
Tipifarnib may stop the growth of breast cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with combination chemotherapy may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with combination chemotherapy and to see how well they work in treating patients with stage II or stage III breast cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Paclitaxel
Tipifarnib
Criteria
Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the breast; clinical stage
IIB, IIIA, IIIB, or IIIC disease

- At least 1 week since prior tamoxifen or other selective estrogen receptor modulator
for prevention or for other indications (e.g., osteoporosis or prior ductal carcinoma
in situ)

- HER-2/neu-negative by immunohistochemistry or fluorescence in situ hybridization
(FISH)

- Hormone receptor status:

- Estrogen and/or progesterone receptor-positive* [Note: *Patients enrolled on the
phase I portion of the trial may have estrogen and progesterone receptor-negative
disease]

- Normal organ function including:

- WBC >= 3,000/mm^3

- Absolute neutrophil count >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Bilirubin normal

- AST and ALT =< 2.5 times upper limit of normal

- LVEF normal by echocardiogram or nuclear scan

- Creatinine normal OR Creatinine clearance >= 60 mL/min

- FEV1 >= 1 L* and DLCO >= 50%* [Note: *Only if baseline CT scan of chest shows
parenchymal lung disease OR there is a history of chronic obstructive or other
pulmonary disease]

- No prior chemotherapy, radiotherapy, or definitive therapeutic surgery (e.g.,
mastectomy, lumpectomy, or axillary dissection) for this cancer but prior sentinel
lymph node biopsy for this malignancy allowed

- No prior adjuvant chemotherapy for a previous breast malignancy

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents

- No other concurrent anticancer agents or therapies

- ECOG performance status 0-1

- Fertile patients must use effective contraception

Exclusion criteria:

- No other invasive malignancy within the past 5 years except curatively treated basal
cell or squamous cell skin cancer or carcinoma in situ of the cervix

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to tipifarnib or other study drugs (e.g., imidazoles or
quinolones)

- No other uncontrolled illness including, but not limited to, any of the following:
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia or psychiatric illness/social situations that would
preclude study compliance

- Not pregnant or nursing