Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma
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| ClinicalTrials.gov Identifier: NCT00056173 |
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Recruitment Status :
Completed
First Posted : March 10, 2003
Last Update Posted : January 7, 2008
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Sponsor:
Aptose Biosciences Inc.
Collaborators:
Wake Forest University
University of Chicago
Information provided by:
Aptose Biosciences Inc.
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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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | March 2002 |
| Actual Primary Completion Date : | December 2004 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Capecitabine
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056173
Locations
| United States, California | |
| Bay Area Cancer Research Group | |
| Concord, California, United States, 94520 | |
| USC-Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033 | |
| CA Hematology Oncology Medical Group | |
| Torrance, California, United States, 90505 | |
| United States, Florida | |
| Innovative Medical Research of South Florida, Inc. | |
| Miami Shores, Florida, United States, 33138 | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, New York | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Comprehensive Cancer Center of Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
Sponsors and Collaborators
Aptose Biosciences Inc.
Wake Forest University
University of Chicago
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00056173 History of Changes |
| Obsolete Identifiers: | NCT00084331 |
| Other Study ID Numbers: |
L01-1409 |
| First Posted: | March 10, 2003 Key Record Dates |
| Last Update Posted: | January 7, 2008 |
| Last Verified: | January 2008 |
Keywords provided by Aptose Biosciences Inc.:
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Metastatic Renal Cell Carcinoma |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Renal Cell Neoplasm Metastasis Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Neoplastic Processes Pathologic Processes Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |