Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
SuperGen |
---|---|
Information provided by: | SuperGen |
ClinicalTrials.gov Identifier: | NCT00113256 |
Patients will be treated with gemcitabine and Orathecin (rubitecan) capsules to evaluate the current estimate of overall survival as a study endpoint prior to launching the blinded randomized phase (versus gemcitabine and placebo) of the study. Toxicity of the drug combination will also be evaluated.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: Rubitecan |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial of Orathecin and Gemcitabine Versus Placebo and Gemcitabine in Patients With Non-Resectable Pancreatic Cancer Who Have Not Already Received Chemotherapy |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jocelyn Rojas, RN | 925-560-0100 ext 424 | |
Contact: Mag Sohal | 925-560-0100 ext 416 |
United States, California | |
11100 Warner Avenue, Ste. 200 | Recruiting |
Fountain Valley, California, United States, 92708 | |
Principal Investigator: Robert Moss, MD | |
The Cancer Research & Prevention Center | Recruiting |
Soquel, California, United States, 95073 | |
Principal Investigator: J. Talisman Pomeroy, MD | |
Compassionate Cancer Care Medical Group | Recruiting |
Corona, California, United States, 92882 | |
Principal Investigator: Yudhishtra Markan, MD | |
United States, Colorado | |
Mile High Oncology | Recruiting |
Denver, Colorado, United States, 80210 | |
Principal Investigator: David Schrier, MD | |
United States, Kentucky | |
Norton Healthcare, Inc. | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Principal Investigator: John T. Hamm, MD | |
United States, Louisiana | |
Medical Oncology | Recruiting |
Baton Rouge, Louisiana, United States, 70809 | |
Principal Investigator: Michael Castine, MD | |
Mary Bird Perkins Cancer Center | Recruiting |
Baton Rouge, Louisiana, United States, 70809 | |
Principal Investigator: Judd E. Patten, MD, PhD | |
United States, Mississippi | |
N. Mississippi Hematology & Oncology Associates | Recruiting |
Tupelo, Mississippi, United States, 38801 | |
Principal Investigator: Christopher Croot, MD | |
United States, Missouri | |
Kansas City Cancer Center | Recruiting |
Kansas City, Missouri, United States, 64111 | |
Principal Investigator: Robert J. Belt, MD | |
United States, New York | |
Cancer Research of Long Island | Recruiting |
Great Neck, New York, United States, 11023 | |
Principal Investigator: Hal Gerstein, MD | |
United States, South Carolina | |
Charleston Hematology Oncology, PA | Recruiting |
Charleston, South Carolina, United States, 29403 | |
Principal Investigator: David Ellison, MD |
Study ID Numbers: | SGI-RUB-048 |
Study First Received: | June 6, 2005 |
Last Updated: | February 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00113256 |
Health Authority: | United States: Food and Drug Administration |
rubitecan Orathecin 9-nitrocamptothecin gemcitabine |
Gemzar pancreatic cancer adenocarcinoma RFS 2000 |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms |
Endocrinopathy 9-nitrocamptothecin Gemcitabine Adenocarcinoma Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |