Tipifarnib Plus Trastuzumab in Treating Patients With Metastatic Breast Cancer

NCT00054470 | Withdrawn Phase 2 DMC

• 6 other identifiers: CDR0000270686U01CA069853P30CA054174SACI-IDD-01-44NCI-5330UTHSC-IDD-01-44
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; male breast cancer

Interventions

trastuzumab BIOLOGICAL

tipifarnib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Trastuzumab; tipifarnib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Garry Schwartz, MD

  Brooke Army Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: December 1, 2002
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2003
• Last Updated: June 29, 2012

Record last verified: 2012-06