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

This study has been completed.
Sponsor:
Collaborators:
Wake Forest School of Medicine
University of Chicago
Information provided by:
Aptose Biosciences Inc.
ClinicalTrials.gov Identifier:
NCT00056173
First received: March 6, 2003
Last updated: January 4, 2008
Last verified: January 2008
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Aptose Biosciences Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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 School of Medicine
University of Chicago
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00056173     History of Changes
Obsolete Identifiers: NCT00084331
Other Study ID Numbers: L01-1409
Study First Received: March 6, 2003
Last Updated: January 4, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 19, 2014