|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | AGO 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 Primary Peritoneal Cavity Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 | |
| Universitaetsklinikum Charite | |
| Berlin, Germany, D-10117 | |
| Zentralkrankenhaus | |
| Bremen, Germany, D-28205 | |
| Medizinische Klinik I | |
| Dresden, Germany, D-01307 | |
| Evangelisches Krankenhaus | |
| Dusseldorf, Germany, DOH-4-0217 | |
| Klinikum der J.W. Goethe Universitaet | |
| Frankfurt, Germany, D-60590 | |
| Staedtisches Krankenhaus FFM-Hoechst | |
| Frankfurt Am Main, Germany, 65929 | |
| Universitaetsklinik Goettingen | |
| Gottingen, Germany, D-37075 | |
| Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet | |
| Greifswald, Germany, D-17487 | |
| Frauenklinik der MHH | |
| Hannover, Germany, 30659 | |
| Vincentius Krankenhaus | |
| Karlsruhe, Germany, D-76137 | |
| Christian-Albrechts University of Kiel | |
| Kiel, Germany, D-24105 | |
| Klinik der Otto-v.-Guericke-Universitat | |
| Magdeburg, Germany, 39108 | |
| Klinik und Poliklinik fuer Kinderheilkunde | |
| Muenster, Germany, D-48129 | |
| Klinikum Grosshadern | |
| Munich (Muenchen), Germany, D-81377 | |
| Klinikum Rechts Der Isar/Technische Universitaet Muenchen | |
| Munich (Muenchen), Germany, D-81675 | |
| Universitaetsklinikum Tuebingen | |
| Tuebingen, Germany, D-72076 | |
| Universitaet Ulm | |
| Ulm, Germany, D-89075 | |
| Dr. Horst-Schmidt-Kliniken | |
| Wiesbaden, Germany, D-65199 | |
| Study Chair: | Andreas du Bois, MD, PhD | Dr. Horst-Schmidt-Kliniken |
More Information
| ClinicalTrials.gov Identifier: | NCT00031954 History of Changes |
| Other Study ID Numbers: | CDR0000069242, AGOSG-OVAR-8, EU-20146 |
| Study First Received: | March 8, 2002 |
| Last Updated: | April 19, 2011 |
| 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 primary peritoneal cavity cancer |
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Gemcitabine Carboplatin Paclitaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |