A Trial of Thalidomide and Capecitabine in Metastatic Ren... | NCT00226980

Studies
A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

NCT00226980

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 14, 2009Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Kidney Neoplasms

Interventions

Thalidomide
Capecitabine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Jul 2005Actual

Completion Date

Jul 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 23, 2005

First Posted Date

Sep 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2009

Last Update Posted Date

Apr 14, 2009Estimated

Name	Class
Celgene Corporation	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.

Secondary Outcomes

Measure	Description	Time Frame
Safety of the combination

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Sandy Srinivas	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D007680	Kidney Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013792	Thalidomide
D000069287	Capecitabine

Ancestor Terms

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Thalidomide	Drug
Capecitabine	Drug