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Home > "C" Clinical Trials Conditions > Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma  Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma
Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma
For Condition: Carcinoma, Renal Cell,Metastases, Neoplasm
Status: Recruiting
Sponsor(s): Lorus Therapeutics , Wake Forest University,University of Chicago
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 43
Location and Contact Information:
Ochsner Clinic Foundation *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3708
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Nancy Lewis 215-728-4300
Comprehensive Cancer Center of Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Frank Torti 336-716-7971
Innovative Medical Research of South Florida, Inc. *Recruiting*
Miami, Florida, 33138
United States
Recruiting Marc Saltzman 305-759-1881
Bay Area Cancer Research Group *Recruiting*
Concord, California, 94520
United States
Recruiting Robert Robles 925-676-4740
CA Hematology Oncology Medical Group *Recruiting*
Torrance, California, 90505
United States
Recruiting Alex Makalinao 310-792-8873
University of Chicago Medical Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Walter Stadler 773-702-4150
USC-Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting David Quinn 323-865-3956
SUNY Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Bernard Poiesz 315-464-8231
The Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Ronald Bukowski 216-444-6825
Additional Information:
Study ID Numbers: L01-1409;
Study Start Date: March 2002
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056173
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2. A Phase III randomized study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer
3. A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833
4. Advanced Renal Cell Carcinoma
5. A Safety, Tolerability and Efficacy Study of E7070 in Patients with Renal Cell Carcinoma
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Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma
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