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Sponsors and Collaborators: |
AGO Ovarian Cancer Study Group Nordic Society for Gynaecologic Oncology Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052468 |
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. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Multi-National Randomized Phase III GCIG Intergroup Study Comparing 1st Line Chemotherapy With Gemcitabine, Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV |
Study Start Date: | August 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
Some patients undergo interval debulking surgery.
Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study.
Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one of the following:
Ovarian epithelial cancer
The following are ineligible:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No other malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy except:
Radiotherapy
Surgery
Other
Denmark | |
Herlev Hospital - University Hospital of Copenhagen | |
Copenhagen, Denmark, DK2730 | |
France | |
Hotel Dieu de Paris | |
Paris, France, 75181 | |
Germany | |
Dr. Horst-Schmidt-Kliniken | |
Wiesbaden, Germany, D-65199 | |
Evangelisches Krankenhaus | |
Dusseldorf, Germany, DOH-40217 | |
Klinikum Rechts Der Isar - Technische Universitaet Muenchen | |
Munich, Germany, D-81675 | |
Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster | |
Muenster, Germany, D-48129 | |
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen | |
Munich, Germany, D-81377 | |
Frauenklinik der MHH | |
Hannover, Germany, 30659 | |
Staedtische Kliniken Frankfurt am Main - Hoechst | |
Frankfurt, Germany, D-65929 | |
Universitaet Ulm | |
Ulm, Germany, D-89075 | |
Universitaetsklinikum Essen | |
Essen, Germany, D-45122 | |
Universitaetsklinikum Tuebingen | |
Tuebingen, Germany, D-72076 | |
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg | |
Magdeburg, Germany, 39108 | |
University Hospital Schleswig-Holstein - Kiel Campus | |
Kiel, Germany, D-24105 | |
Vincentius Krankenhaus | |
Karlsruhe, Germany, D-76137 | |
Zentralkrankenhaus | |
Bremen, Germany, D-28205 | |
Norway | |
Norwegian Radium Hospital | |
Oslo, Norway, N-0310 |
Study Chair: | Andreas du Bois, MD, PhD | Dr. Horst-Schmidt-Kliniken |
Study Chair: | J. Herrstedt | Copenhagen County Herlev University Hospital |
Study Chair: | E. Pujade-Lauraine, MD, PhD | Hotel Dieu de Paris |
Study ID Numbers: | CDR0000258429, AGO-OVAR-9, NORDIC-AGO-OVAR-9, GERCOR-AGO-OVAR-9, EU-20241 |
Study First Received: | January 24, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00052468 History of Changes |
Health Authority: | United States: Federal Government |
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer |
Antimetabolites Fallopian Tube Cancer Anti-Infective Agents Immunologic Factors Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Ovarian Cancer Gemcitabine Endocrine Gland Neoplasms Ovarian Neoplasms Genital Neoplasms, Female |
Adjuvants, Immunologic Endocrine System Diseases Carboplatin Antimitotic Agents Ovarian Epithelial Cancer Antiviral Agents Immunosuppressive Agents Fallopian Tube Neoplasms Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Endocrinopathy Antineoplastic Agents, Phytogenic |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Gemcitabine Endocrine Gland Neoplasms |
Ovarian Neoplasms Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Antimitotic Agents Carboplatin Immunosuppressive Agents Antiviral Agents Fallopian Tube Neoplasms Pharmacologic Actions Fallopian Tube Diseases Adnexal Diseases Neoplasms Radiation-Sensitizing Agents |