Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma

This study has been completed.

First Received: March 6, 2003 Last Updated: January 4, 2008 History of Changes

Sponsor:	Lorus Therapeutics
Collaborators:	Wake Forest University University of Chicago
Information provided by:	Lorus Therapeutics
ClinicalTrials.gov Identifier:	NCT00056173

Purpose

This phase II, 43 patient trial, will evaluate the efficacy of GTI-2040, an antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase (RNR) mRNA, in combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma. Preclinical studies have shown synergy between GTI-2040 and capecitabine against renal cell carcinoma.

Condition	Intervention	Phase
Carcinoma, Renal Cell Metastases, Neoplasm	Drug: GTI-2040	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Study of GTI-2040 and Capecitabine Combination Therapy in Patients With Advanced or Metastatic Renal Cell Carcinoma (mRCC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Capecitabine GTI2040

U.S. FDA Resources

Further study details as provided by Lorus Therapeutics:

Estimated Enrollment:	43
Study Start Date:	March 2002
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Age greater than or equal to 18.
Histologically or cytologically confirmed diagnosis of advanced or metastatic renal cell carcinoma for which no effective therapy is available or that is unresponsive to conventional therapy.
Measurable disease. To be considered measurable, a lesion must be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan.
Karnofsky performance status of greater than or equal to 70.
Be able to have a central venous like access maintained throughout the study.
Provide written informed consent prior to the initiation of protocol therapy.
Appropriate organ function.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056173

Locations

United States, California
USC-Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
CA Hematology Oncology Medical Group
Torrance, California, United States, 90505
Bay Area Cancer Research Group
Concord, California, United States, 94520
United States, Florida
Innovative Medical Research of South Florida, Inc.
Miami Shores, Florida, United States, 33138
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111

Sponsors and Collaborators

Lorus Therapeutics

Wake Forest University

University of Chicago

More Information

Additional Information:

Lorus Therapeutics Website This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	L01-1409
Study First Received:	March 6, 2003
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00056173 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lorus Therapeutics:

Metastatic Renal Cell Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Urogenital Neoplasms
Urologic Neoplasms
Pharmacologic Actions
Carcinoma
Neoplastic Processes

Neoplasms
Pathologic Processes
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Neoplasm Metastasis
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009