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Home > "T" Clinical Trials Conditions > Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced or Metastatic Breast Cancer  Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced or Metastatic Breast Cancer
Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced or Metastatic Breast Cancer
For Condition: Breast Cancer,inflammatory breast cancer
Status: Recruiting
Sponsor(s): Albert Einstein Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining tipifarnib with doxorubicin and cyclophosphamide may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining tipifarnib with doxorubicin and cyclophosphamide in treating women who have locally advanced or metastatic breast cancer.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of tipifarnib when administered with doxorubicin and cyclophosphamide in women with metastatic breast cancer (non-regional stage IV disease). - Determine the pathologic complete remission rate in patients with locally advanced breast cancer (stages IIB, IIIA, IIIB, or IIIC) treated with the recommended phase II dose of this regimen. Secondary - Determine the clinical complete response rate in patients treated with this regimen. - Determine the toxicity profile of this regimen in these patients. - Correlate pretreatment levels of ErbB1, 2, 3, 4 and phosphorylated levels of Akt, STAT3, and Erk 1/2 with clinical response in these patients and with percent inhibition of proliferation (Ki-67) and percent induction of apoptosis in post-treatment tumor specimens. - Correlate percent decrease of farnesyltransferase (FTase) activity levels, HDJ-2 farnesylation, phospho-Akt, phospho-STAT3, and phospho-Erk 1/2 with clinical response rates in these patients and with percent inhibition of proliferation (Ki-67) and percent inhibition of apoptosis. OUTLINE: This is a multicenter, dose-escalation study of tipifarnib. Patients are stratified according to presence of inflammatory carcinoma (yes vs no). - 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 filgrastim (G-CSF) subcutaneously on days 2-13. Treatment repeats every 2 weeks for 4 courses 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 2 of 3 or 2 of 6 patients experience dose-limiting 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. After the fourth course, patients may undergo complete resection. Patients are followed every 3-4 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 3-12 patients will be accrued for phase I of this study. A total of 21-50 patients will be accrued for phase II of this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the breast - Phase I: - 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 PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-1 OR - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - LVEF normal - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - 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 - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Phase I: - 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 if the following are true: - Used in adjuvant setting - Cumulative dose no greater than 240 mg/m^2 - At least 1 year between completion of adjuvant therapy and relapse - Phase II: - No prior chemotherapy for breast cancer Endocrine therapy - 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) Radiotherapy - Phase I: - More than 4 weeks since prior radiotherapy - Phase II: - No prior radiotherapy for breast cancer Surgery - Not specified Other - No antacids within 2 hours of study drug administration - No other concurrent investigational or commercial agents or therapies with the intent to treat breast cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephSparano, Study Chair, Albert Einstein Cancer Research Center
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Daniel Budman 516-562-8958
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Kapil Bhalla 813-903-6861
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Linda Vahdat 212-861-0644
Jacobi Medical Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Manuel Macapinlac 718-918-5000
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting George Raptis 212-241-6631
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
Additional Information:
Study ID Numbers: CDR0000257811; NCI-5598,AECM-0205125
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049114
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Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced or Metastatic Breast Cancer
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