A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-07-31

Brief Summary

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The purpose of this study is to determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma and also to determine the safety of the combination.

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Detailed Description

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Conditions

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Kidney Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Thalidomide

Intervention Type DRUG

Capecitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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