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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00056173
Recruitment Status : Completed
First Posted : March 10, 2003
Last Update Posted : January 7, 2008
Wake Forest University
University of Chicago
Information provided by:
Aptose Biosciences Inc.

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Metastases, Neoplasm Drug: GTI-2040 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of GTI-2040 and Capecitabine Combination Therapy in Patients With Advanced or Metastatic Renal Cell Carcinoma (mRCC)
Study Start Date : March 2002
Actual Primary Completion Date : December 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00056173

United States, California
Bay Area Cancer Research Group
Concord, California, United States, 94520
USC-Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
CA Hematology Oncology Medical Group
Torrance, California, United States, 90505
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
Aptose Biosciences Inc.
Wake Forest University
University of Chicago

Additional Information: Identifier: NCT00056173     History of Changes
Obsolete Identifiers: NCT00084331
Other Study ID Numbers: L01-1409
First Posted: March 10, 2003    Key Record Dates
Last Update Posted: January 7, 2008
Last Verified: January 2008

Keywords provided by Aptose Biosciences Inc.:
Metastatic Renal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents