Status:
COMPLETED
Tipifarnib and Fulvestrant in Hormone Receptor-Positive Metastatic Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Estrogen Receptor-positive Breast Cancer
Recurrent Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving tipifarnib together with fulvestrant works as second-line therapy in treating postmenopausal women with hormone receptor-positive inoperable locally adv...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the efficacy of tipifarnib (R115777, Zarnestra™) in combination with fulvestrant based on clinical benefit rate (CBR, a combination of complete response rate, part...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed adenocarcinoma of the breast
- Patients must be postmenopausal
- Patients must have stage IV disease or inoperable locally advanced disease
- Patients must have ER- and/or PR-positive disease as determined by their local pathology laboratory
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan; all sites of disease should be noted and followed
- Prior hormonal therapy as adjuvant therapy and/or for metastatic disease is permitted; patients previously treated with two or more prior doses of fulvestrant are not eligible; patients who have received one prior dose of fulvestrant within 28 days are eligible so long as they meet other eligibility criteria
- Patients must have ECOG performance status 0-2 (Karnofsky \>= 60%)
- Patients must have life expectancy of greater than 3 months
- Leukocytes \>= 3,000/uL
- Absolute neutrophil count \>= 1,500/uL
- Platelets \>= 100,000/uL
- Total bilirubin =\< 2 mg/dL
- AST(SGOT)/ALT(SGPT) =\< 2.5 x institutional upper limit of normal
- Creatinine less than or equal to 1.5 times the institutional upper limits of normal
- Patients must be disease-free of prior invasive malignancies for \>= 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix
- Patients must have the ability to understand and the willingness to sign a written informed consent document
- Patients who have had previous therapy with farnesyltransferase inhibitor
Exclusion
- Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have had prior chemotherapy for metastatic disease are not eligible; prior adjuvant or neoadjuvant chemotherapy is allowed
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777, Zarnestra™) or other agents used in the study (e.g., imidazoles, quinolones)
- Presence of rapidly progressive, life-threatening metastases; this includes patients with extensive hepatic involvement (\> 50% of the liver involved), symptomatic lymphangitic metastases, or brain or leptomeningeal involvement
- Concomitant anticancer treatment with the following exceptions: (1) bisphosphonates for bone metastases, (2) a GnRH analog is permitted if the patient had progressive disease on a GnRH analog plus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be discontinued
- Grade 2 or more peripheral neuropathy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with tipifarnib or other agents administered during the study.; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00082810
Start Date
March 1 2004
End Date
September 1 2008
Last Update
November 1 2018
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467-2490