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

Tracking Information
First Received Date ^ICMJE	March 6, 2003
Last Updated Date	January 4, 2008
Start Date ^ICMJE	March 2002
Primary Completion Date	December 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00056173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma
Official Title ^ICMJE	A Phase I/II Study of GTI-2040 and Capecitabine Combination Therapy in Patients With Advanced or Metastatic Renal Cell Carcinoma (mRCC)
Brief Summary	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.
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Carcinoma, Renal Cell Metastases, Neoplasm
Intervention ^ICMJE	Drug: GTI-2040
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	43
Completion Date
Primary Completion Date	December 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00056173
Responsible Party
Study ID Numbers ^ICMJE	L01-1409
Study Sponsor ^ICMJE	Lorus Therapeutics
Collaborators ^ICMJE	Wake Forest University University of Chicago
Investigators ^ICMJE
Information Provided By	Lorus Therapeutics
Verification Date	January 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP