A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT00226980|
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : April 14, 2009
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|Condition or disease||Intervention/treatment||Phase|
|Kidney Neoplasms||Drug: Thalidomide Drug: Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2006|
- Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
- Safety of the combination
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria:- Able to comprehend and sign an IRB approved Informed consent
- Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program.
- Male or female 18 years or older
- Willing to use contraception
- Pathologic diagnosis of renal cell carcinoma
- Bi-dimensionally measurable disease
- Evidence of disease progression prior to start of treatment
- Failed prior immunotherapy or unwilling/unable to receive prior immunotherapy
- Adequate hematologic data: ANC.1.5; platelets>100x10^9
- Adequate renal function: Creatinine clearance .50cc
- Adequate liver function: Alkaline phos <3XULN AST/ALT <3XULN T.Bili <1.5XULN
- ECOG performance status 0-1 Exclusion Criteria:- Known brain metastases.
- Peripheral neuropathy.
- Pregnant and/ or lactating female.
- Unable to take a baby aspirin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226980
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dr. Sandy Srinivas||Stanford University|
|Responsible Party:||Sandy Srinivas, Principal Investigator, Stanford University School of Medicine|
|Other Study ID Numbers:||
|First Posted:||September 27, 2005 Key Record Dates|
|Last Update Posted:||April 14, 2009|
|Last Verified:||April 2009|
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Angiogenesis Modulating Agents