Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
San Antonio Cancer Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00054470 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: tipifarnib Drug: trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Study Start Date: | March 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive oral tipifarnib twice daily on days 1-21 and trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 18-40 patients will be accrued for this study within 9-20 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
HER2/neu 3+ by immunohistochemical staining
Unidimensionally measurable disease
Patients with known brain metastases meeting any of the following criteria are not eligible:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Texas | |
Brooke Army Medical Center | |
Fort Sam Houston, Texas, United States, 78234 | |
San Antonio Cancer Institute | |
San Antonio, Texas, United States, 78229-3264 |
Study Chair: | Garry Schwartz, MD | Brooke Army Medical Center |
Study ID Numbers: | CDR0000270686, SACI-IDD-01-44, NCI-5330, UTHSC-IDD-01-44 |
Study First Received: | February 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00054470 |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer male breast cancer |
Skin Diseases Breast Neoplasms, Male Trastuzumab Breast Neoplasms |
Breast Diseases Recurrence Tipifarnib |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |