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| Sponsored by: |
AGO Ovarian Cancer Study Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031954 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV |
| Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 and 6 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Germany | |
| Christian-Albrechts University of Kiel | |
| Kiel, Germany, D-24105 | |
| Dr. Horst-Schmidt-Kliniken | |
| Wiesbaden, Germany, D-65199 | |
| Evangelisches Krankenhaus | |
| Dusseldorf, Germany, DOH-4-0217 | |
| Frauenklinik der MHH | |
| Hannover, Germany, 30659 | |
| Klinik der Otto-v.-Guericke-Universitat | |
| Magdeburg, Germany, 39108 | |
| Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet | |
| Greifswald, Germany, D-17487 | |
| Klinik und Poliklinik fuer Kinderheilkunde | |
| Muenster, Germany, D-48129 | |
| Klinikum der J.W. Goethe Universitaet | |
| Frankfurt, Germany, D-60590 | |
| Klinikum Grosshadern | |
| Munich (Muenchen), Germany, D-81377 | |
| Zentralkrankenhaus | |
| Bremen, Germany, D-28205 | |
| Medizinische Klinik I | |
| Dresden, Germany, D-01307 | |
| Staedtisches Krankenhaus FFM-Hoechst | |
| Frankfurt Am Main, Germany, 65929 | |
| Universitaet Ulm | |
| Ulm, Germany, D-89075 | |
| Universitaetsklinik Goettingen | |
| Gottingen, Germany, D-37075 | |
| Universitaetsklinikum Charite | |
| Berlin, Germany, D-10117 | |
| Universitaetsklinikum Tuebingen | |
| Tuebingen, Germany, D-72076 | |
| Vincentius Krankenhaus | |
| Karlsruhe, Germany, D-76137 | |
| Klinikum Rechts Der Isar/Technische Universitaet Muenchen | |
| Munich (Muenchen), Germany, D-81675 | |
| Study Chair: | Andreas du Bois, MD, PhD | Dr. Horst-Schmidt-Kliniken |
More Information
| Study ID Numbers: | CDR0000069242, AGOSG-OVAR-8, EU-20146 |
| Study First Received: | March 8, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00031954 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II ovarian epithelial cancer stage I ovarian epithelial cancer stage III ovarian epithelial cancer |
stage IV ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
|
Antimetabolites Fallopian Tube Cancer Immunologic Factors Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Peritoneal Diseases Ovarian Cancer Gemcitabine Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases |
Antimitotic Agents Carboplatin Abdominal Neoplasms Ovarian Epithelial Cancer Immunosuppressive Agents Antiviral Agents Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases Digestive System Diseases Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Peritoneal Neoplasms |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Gemcitabine |
Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Antimitotic Agents Carboplatin Abdominal Neoplasms Immunosuppressive Agents Antiviral Agents Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases |