Back to resultsCombination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma
Primary Purpose
Carcinoma, Renal Cell, Metastases, Neoplasm
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GTI-2040
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Metastatic Renal Cell Carcinoma
Eligibility 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.
Sites / Locations
- Bay Area Cancer Research Group
- USC-Norris Comprehensive Cancer Center and Hospital
- CA Hematology Oncology Medical Group
- Innovative Medical Research of South Florida, Inc.
- University of Chicago Medical Center
- Ochsner Clinic Foundation
- SUNY Upstate Medical University
- Comprehensive Cancer Center of Wake Forest University
- The Cleveland Clinic Foundation
- Fox Chase Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00056173
First Posted
March 6, 2003
Last Updated
January 4, 2008
Sponsor
Aptose Biosciences Inc.
Collaborators
Wake Forest University, University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00056173
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 Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Aptose Biosciences Inc.
Collaborators
Wake Forest University, University of Chicago
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Metastases, Neoplasm
Keywords
Metastatic Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GTI-2040
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Bay Area Cancer Research Group
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
USC-Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
CA Hematology Oncology Medical Group
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Innovative Medical Research of South Florida, Inc.
City
Miami Shores
State/Province
Florida
ZIP/Postal Code
33138
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.lorusthera.com
Description
Lorus Therapeutics Website
Learn more about this trial
Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma
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