Breast Cancer Clinical Trial
Official title:
A Phase II Evaluation Of The Efficacy And Safety Of R115777 (NSC702818) A Non-Peptidomimetic Farnesyl Transferase Inhibitor, And Trastuzumab In Patients With Advanced Breast Cancer
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary
for tumor cell growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and
either kill them or deliver tumor-killing substances to them without harming normal cells.
Combining tipifarnib with trastuzumab may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with trastuzumab
in treating patients who have metastatic breast cancer.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2003 |
Est. primary completion date | January 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic adenocarcinoma of the breast - HER2/neu 3+ by immunohistochemical staining - 2+ eligible provided HER2/neu positive by fluorescent in-situ hybridization (FISH) - HER2/neu positive by FISH alone allowed - Unidimensionally measurable disease - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Must have received prior trastuzumab (Herceptin) - Patients with known brain metastases meeting any of the following criteria are not eligible: - Require high-dose steroid therapy or enzyme-inducing anticonvulsant drugs - No prior cranial radiotherapy - Have progressive neurologic dysfunction that would preclude study evaluation - Have evidence of progressive CNS disease by CT scan or MRI - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - Over 18 Sex - Male or female Menopausal status - Not specified Performance status - ECOG 0-2 OR - Karnofsky 70-100% Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance greater than 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - Ejection fraction greater than 50% by MUGA or echocardiogram Gastrointestinal - No gastrointestinal tract disease resulting in an inability to tolerate oral medication - No requirement for IV alimentation - No active peptic ulcer disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No significant traumatic injury within the past 21 days - No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No ongoing or active infection - No prior allergic reaction attributed to compounds of similar chemical or biological composition to tipifarnib (e.g., quinolones) or trastuzumab - No psychiatric illness or social situation that would preclude study compliance - No other concurrent medical illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior bone marrow transplantation with high-dose chemotherapy - No concurrent immunotherapy Chemotherapy - See Biologic therapy - No more than 2 prior chemotherapy regimens for metastatic disease - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior combination chemotherapy allowed - No concurrent chemotherapy Endocrine therapy - See Disease Characteristics - Prior hormonal therapy allowed - No concurrent hormonal therapy for cancer Radiotherapy - See Disease Characteristics - More than 4 weeks since prior wide-field radiotherapy and recovered - No concurrent radiotherapy Surgery - Prior modified radical mastectomy or lumpectomy with axillary node dissection allowed - Prior resection of metastatic lesions allowed - More than 21 days since prior major surgery - No prior surgery affecting absorption Other - No prior tipifarnib - More than 6 weeks since initiation of bisphosphonate therapy (if bone lesions are the only site of measurable disease) - Bisphosphonate therapy may not be initiated during study - No other concurrent investigational agents - No other concurrent anticancer therapy - No concurrent antacids within 2 hours of study drug |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | National Cancer Institute (NCI) |
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