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A Phase I/II Study of GTI-2040 and Capecitabine Combination Therapy in Patients With Advanced or Metastatic Renal Cell Carcinoma (mRCC)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell, Metastases, Neoplasm

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Trial Information

A Phase I/II Study of GTI-2040 and Capecitabine Combination Therapy in Patients With Advanced or Metastatic Renal Cell Carcinoma (mRCC)

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

L01-1409

NCT ID:

NCT00056173

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Carcinoma, Renal Cell
  • Metastases, Neoplasm
  • Metastatic Renal Cell Carcinoma
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
SUNY Upstate Medical UniversitySyracuse, New York  13210
Innovative Medical Research of South Florida, Inc.Miami, Florida  33138
University of Chicago Medical CenterChicago, Illinois  60637
The Cleveland Clinic FoundationCleveland, Ohio  
Bay Area Cancer Research GroupConcord, California  94520
USC-Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033
CA Hematology Oncology Medical GroupTorrance, California  90505
Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina  27157-1082