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

Sponsor

Aptose Biosciences Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00056173

Collaborator

Wake Forest University (Other), University of Chicago (Other)

Enrollment

Locations

4.3

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell Metastases, Neoplasm	Drug: GTI-2040	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

43 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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)

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

Dec 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Bay Area Cancer Research Group	Concord	California	United States	94520
2	USC-Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033
3	CA Hematology Oncology Medical Group	Torrance	California	United States	90505
4	Innovative Medical Research of South Florida, Inc.	Miami Shores	Florida	United States	33138
5	University of Chicago Medical Center	Chicago	Illinois	United States	60637
6	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
7	SUNY Upstate Medical University	Syracuse	New York	United States	13210
8	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
9	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
10	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111