Skip to main content
OpenTrials
Completed

NCT Number: NCT00226980

A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

thalidomide

Drug

Capecitabine

Drug

Primary outcomes

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

Secondary outcomes

  1. Safety of the combination

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Celgene Corporation

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2006
First posted
Sep 27, 2005
Registry last updated
Apr 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.