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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033514 |
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: erlotinib hydrochloride Drug: trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study Of Herceptin Combined With OSI-774 In The First-Line Treatment Of Metastatic Breast Cancer Associated With HER2/Neu Overexpression |
Estimated Enrollment: | 18 |
Study Start Date: | August 2001 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of erlotinib. (Phase I closed to accrual as of 01/2004).
Patients receive oral erlotinib once daily beginning on day 2 and trastuzumab (Herceptin) IV over 30-90 minutes (1-4 hours after erlotinib) once weekly beginning on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib 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. Once the MTD is determined, additional patients are treated at the recommended phase II dose.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for the phase I portion (closed to accrual as of 01/2004) and 27-81 patients will be accrued for the phase II portion of this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic adenocarcinoma of the breast
Histologically documented primary breast cancer or biopsy of metastatic site demonstrating HER2/neu gene amplification by fluorescence in situ hybridization, as evidence by 1 of the following:
Bidimensionally measurable disease
No symptomatic or untreated brain metastases unless both of the following are true:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Phase I patients (closed to accrual as of 01/2004):
Other:
Phase I patients (closed to accrual as of 01/2004):
Phase I (closed to accrual as of 01/2004) and II patients:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Phase I patients (closed to accrual as of 01/2004):
Phase II patients:
Phase I (closed to accrual as of 01/2004) and II patients:
Chemotherapy:
Phase I patients (closed to accrual as of 01/2004):
Phase II patients:
Phase I (closed to accrual as of 01/2004) and II patients:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 |
Study Chair: | Carolyn Britten, MD | Jonsson Comprehensive Cancer Center |
Responsible Party: | Jonsson Comprehensive Cancer Center at UCLA ( Carolyn Britten ) |
Study ID Numbers: | CDR0000069295, UCLA-0106020, GENENTECH-OSI2365s, NCI-G02-2057 |
Study First Received: | April 9, 2002 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00033514 |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer |
Erlotinib Skin Diseases Trastuzumab |
Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |