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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00059852 |
RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with erlotinib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with erlotinib in treating patients who have metastatic breast cancer that has been previously treated with an anthracycline and/or a taxane.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of OSI-774 (Tarceva) and Gemcitabine for Patients With Metastatic Breast Cancer |
Study Start Date: | June 2003 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV on days 1 and 8 and oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response are followed every 6 weeks for up to 5 years or until disease progression (PD). Patients discontinuing study therapy for any other reason are followed every 3 months until PD and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 5-56 patients will be accrued for this study within 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 breast cancer
At least 1 measurable lesion at least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan
The following are not considered measurable disease:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Ophthalmic
Other
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Edith A. Perez, MD | Mayo Clinic |
Investigator: | Stephan Thome, MD | Oncology Hematology West, PC - Omaha Bergan |
Study ID Numbers: | CDR0000298778, NCCTG-N0234 |
Study First Received: | May 6, 2003 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00059852 History of Changes |
Health Authority: | United States: Federal Government |
male breast cancer recurrent breast cancer stage IV breast cancer |
Erlotinib Antimetabolites Skin Diseases Immunologic Factors Breast Neoplasms Breast Cancer, Male Protein Kinase Inhibitors Antiviral Agents |
Immunosuppressive Agents Recurrence Radiation-Sensitizing Agents Breast Neoplasms, Male Gemcitabine Taxane Breast Diseases |
Erlotinib Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors |
Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine Breast Diseases |