A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Thalidomide

Capecitabine

About this trial

This is an interventional treatment trial for Kidney Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stanford University School of Medicine

Outcomes

Primary Outcome Measures

Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.

Secondary Outcome Measures

Safety of the combination

Full Information

NCT ID

NCT00226980

First Posted

September 13, 2005

Last Updated

April 10, 2009

Sponsor

Stanford University

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00226980

Brief Title

A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

Official Title

A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

July 2005 (Actual)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Stanford University

Collaborators

Celgene Corporation

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Thalidomide

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Primary Outcome Measure Information:

Title

Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.

Secondary Outcome Measure Information:

Title

Safety of the combination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Sandy Srinivas

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Kidney Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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