Status:
COMPLETED
Tipifarnib and Combination Chemotherapy in Treating Patients With Stage II or Stage III Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Male Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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, doxorubi...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the recommended phase II dose of tipifarnib when given together with paclitaxel in patients with stage IIB-IIIC breast cancer. (Phase I) II. To determine the patho...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00470301
Start Date
April 1 2007
End Date
September 1 2013
Last Update
February 16 2021
Active Locations (7)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
2
Mount Sinai Medical Center
New York, New York, United States, 10029
3
Columbia University Medical Center
New York, New York, United States, 10032
4
Weill Medical College of Cornell University
New York, New York, United States, 10065