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Tracking Information | |||||||||
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First Received Date ICMJE | May 6, 2003 | ||||||||
Last Updated Date | February 4, 2009 | ||||||||
Start Date ICMJE | June 2003 | ||||||||
Current Primary Outcome Measures ICMJE | |||||||||
Original Primary Outcome Measures ICMJE | |||||||||
Change History | Complete list of historical versions of study NCT00059852 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE | |||||||||
Original Secondary Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane | ||||||||
Official Title ICMJE | A Phase II Study of OSI-774 (Tarceva) and Gemcitabine for Patients With Metastatic Breast Cancer | ||||||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase II | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Design ICMJE | Treatment, Open Label | ||||||||
Condition ICMJE | Breast Cancer | ||||||||
Intervention ICMJE |
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Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Enrollment ICMJE | |||||||||
Completion Date | |||||||||
Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Ophthalmic
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID ICMJE | NCT00059852 | ||||||||
Responsible Party | |||||||||
Study ID Numbers ICMJE | CDR0000298778, NCCTG-N0234 | ||||||||
Study Sponsor ICMJE | North Central Cancer Treatment Group | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | September 2004 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |