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| ID | Type | Description | Link |
|---|---|---|---|
| AGOSG-OVAR-8 | |||
| EU-20146 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| gemcitabine hydrochloride | Drug | |||
| paclitaxel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity | The decision level is reached, when the lower exact 95% confidence limit of the observed proportion is higher than the upper exact 95% confidence limit of the historical proportion, which corresponds to a power of 0.5 applying a significance level of 0.05 | Based on decision level |
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DISEASE CHARACTERISTICS:
Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas du Bois, MD, PhD | Dr. Horst-Schmidt-Kliniken | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Charite | Berlin | D-10117 | Germany | |||
| Zentralkrankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15661234 | Result | du Bois A, Belau A, Wagner U, Pfisterer J, Schmalfeldt B, Richter B, Staehle A, Jackisch C, Lueck HJ, Schroeder W, Burges A, Olbricht S, Elser G; Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR). A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8). Gynecol Oncol. 2005 Feb;96(2):444-51. doi: 10.1016/j.ygyno.2004.10.020. |
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| Bremen |
| D-28205 |
| Germany |
| Medizinische Klinik I | Dresden | D-01307 | Germany |
| Evangelisches Krankenhaus | Düsseldorf | DOH-4-0217 | Germany |
| Klinikum der J.W. Goethe Universitaet | Frankfurt | D-60590 | Germany |
| Staedtisches Krankenhaus FFM-Hoechst | Frankfurt am Main | 65929 | Germany |
| Universitaetsklinik Goettingen | Göttingen | D-37075 | Germany |
| Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet | Greifswald | D-17487 | Germany |
| Frauenklinik der MHH | Hanover | 30659 | Germany |
| Vincentius Krankenhaus | Karlsruhe | D-76137 | Germany |
| Christian-Albrechts University of Kiel | Kiel | D-24105 | Germany |
| Klinik der Otto-v.-Guericke-Universitat | Magdeburg | 39108 | Germany |
| Klinikum Grosshadern | Munich (Muenchen) | D-81377 | Germany |
| Klinikum Rechts Der Isar/Technische Universitaet Muenchen | Munich (Muenchen) | D-81675 | Germany |
| Klinik und Poliklinik fuer Kinderheilkunde | Münster | D-48129 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | D-72076 | Germany |
| Universitaet Ulm | Ulm | D-89075 | Germany |
| Dr. Horst-Schmidt-Kliniken | Wiesbaden | D-65199 | Germany |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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