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Sponsors and Collaborators: |
USC/Norris Comprehensive Cancer Center Sanofi-Aventis |
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Information provided by: | USC/Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00183820 |
This is a study for patients with advanced testicular cancer. This research study involves treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational chemotherapy combination. This study is for patients who have not responded to standard cisplatin-containing chemotherapy or the cancer has returned after such treatment.
This research is being done to assess the effectiveness of the proposed combination of medications for this type of cancer.
Condition | Intervention | Phase |
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Testicular Cancer Germ Cell Neoplasm |
Drug: paclitaxel, gemcitabine, and oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma |
Estimated Enrollment: | 20 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: paclitaxel, gemcitabine, and oxaliplatin
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must have refractory germ cell neoplasm defined as one or more of the following:
Must have one or more of the following (check all that apply):
Note: Soft tissue dz, which has been radiated in the 2 months prior to registration, is not assessable as measurable dz.
Exclusion Criteria:
Contact: David Quinn, MD | 323-865-0470 | diquinn@usc.edu |
United States, California | |
Norris Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: David Quinn, MD 323-865-0470 diquinn@usc.edu |
Principal Investigator: | David Quinn, MD | USC/Norris Comprehensive Cancer Center |
Responsible Party: | University of Southern California ( Dr. David Quinn ) |
Study ID Numbers: | 4T-03-1 |
Study First Received: | September 9, 2005 |
Last Updated: | July 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00183820 History of Changes |
Health Authority: | United States: Institutional Review Board |
Testicular Extra gonadal germ cell neoplasm |
Antimetabolites Anti-Infective Agents Genital Neoplasms, Male Immunologic Factors Gonadal Disorders Urogenital Neoplasms Oxaliplatin Neoplasms, Germ Cell and Embryonal Gemcitabine Extragonadal Germ Cell Tumor Endocrine Gland Neoplasms Testicular Cancer Testicular Diseases |
Endocrine System Diseases Testicular Neoplasms Antimitotic Agents Genital Diseases, Male Antiviral Agents Immunosuppressive Agents Carcinoma Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Endocrinopathy Antineoplastic Agents, Phytogenic |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Oxaliplatin Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Gemcitabine |
Endocrine Gland Neoplasms Neoplasms by Histologic Type Mitosis Modulators Testicular Diseases Endocrine System Diseases Enzyme Inhibitors Antimitotic Agents Testicular Neoplasms Genital Diseases, Male Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Paclitaxel |