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Brief Title: Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma
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 ID: NCT00056173
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Bay Area Cancer Research Group, Concord, California, United States
USC-Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
CA Hematology Oncology Medical Group, Torrance, California, United States
Innovative Medical Research of South Florida, Inc., Miami Shores, Florida, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States