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Tracking Information | |||||||||||||
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First Received Date † | May 6, 2003 | ||||||||||||
Last Updated Date | July 23, 2008 | ||||||||||||
Start Date † | May 2003 | ||||||||||||
Current Primary Outcome Measures † |
Response probability [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00060307 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||||||
Brief Title † | Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer | ||||||||||||
Official Title † | A Phase II Study of OSI-774 (NSC-718781) in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer | ||||||||||||
Brief Summary | RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20 months. |
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Study Phase | Phase II | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Open Label | ||||||||||||
Condition † | Kidney Cancer | ||||||||||||
Intervention † | Drug: erlotinib hydrochloride | ||||||||||||
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 † | Active, not recruiting | ||||||||||||
Enrollment † | |||||||||||||
Completion Date | |||||||||||||
Primary Completion Date | |||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Ophthalmic
Gastrointestinal
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 †† | |||||||||||||
Location Countries † | United States | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00060307 | ||||||||||||
Responsible Party | |||||||||||||
Secondary IDs †† | SWOG-S0317, ECOG-S0317 | ||||||||||||
Study Sponsor † | Southwest Oncology Group | ||||||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||
Verification Date | January 2006 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |