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

NCT00056173 | Completed Phase 1

• 1 other identifier: L01-1409
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 10

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.

Conditions

Carcinoma, Renal Cell; Metastases, Neoplasm

Keywords

Metastatic Renal Cell Carcinoma

Interventions

GTI-2040 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Aptose Biosciences Inc.: lead
• Wake Forest University: collaborator
• University of Chicago: collaborator

Study Sites (10)

Bay Area Cancer Research Group

Concord, California, 94520, United States

Location

USC-Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

CA Hematology Oncology Medical Group

Torrance, California, 90505, United States

Location

Innovative Medical Research of South Florida, Inc.

Miami Shores, Florida, 33138, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Links

• Lorus Therapeutics Website

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

GTI2040

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 10, 2003
• Study Start: March 1, 2002
• Primary Completion: December 1, 2004
• Last Updated: January 7, 2008

Record last verified: 2008-01

Locations

US (10)