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

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

This study has been completed.

Sponsors and Collaborators:	Lorus Therapeutics 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

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Capecitabine GTI2040

U.S. FDA Resources

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)

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

Lorus Therapeutics Website This link exits the ClinicalTrials.gov site

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

Keywords provided by Lorus Therapeutics:

Metastatic Renal Cell Carcinoma

Study placed in the following topic categories:

Capecitabine

Urogenital Neoplasms

Renal cancer

Urologic Neoplasms

Kidney cancer

Carcinoma

Urologic Diseases

Kidney Neoplasms

Neoplasm Metastasis

Carcinoma, Renal Cell

Kidney Diseases

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites

Neoplastic Processes

Neoplasms

Antimetabolites, Antineoplastic

Pathologic Processes

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008