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Tracking Information | |||||
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First Received Date † | November 16, 2006 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date † | May 2004 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00401128 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer | ||||
Official Title † | Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma | ||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is an open-label study. Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of unacceptable toxicity or disease progression. After completion of study treatment, patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Kidney Cancer | ||||
Intervention † |
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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 † | Completed | ||||
Enrollment † | 30 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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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 † | NCT00401128 | ||||
Responsible Party | |||||
Secondary IDs †† | CASE-CCF-6695 | ||||
Study Sponsor † | Case Comprehensive Cancer Center | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | May 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |