Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer (AGO-OVAR9)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV|
- Overall Survival [ Time Frame: Whole Study Period ] [ Designated as safety issue: No ]Survival time is calculated from the date of enrollment into the study until the date of death from any cause
- Progression Free Survival [ Time Frame: Whole Study Period ] [ Designated as safety issue: No ]The progression-free survival is calculated for all patients from the date of enrollment until the date of first progressive disease or death, whichever occurs first
- Quality of Life [ Time Frame: Whole Study Period ] [ Designated as safety issue: No ]
|Study Start Date:||August 2002|
|Study Completion Date:||January 2011|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses
Other Name: Paclitaxel/Carboplatin/Gemcitabine
Active Comparator: TC
Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses
Other Name: Paclitaxel/Carboplatin
- Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian tube cancer treated with adjuvant carboplatin and paclitaxel with or without gemcitabine.
- Compare response rates, progression-free survival, and duration of response in patients treated with these regimens.
- Compare toxic effects of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
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.
- Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
- Arm II: Patients receive carboplatin and paclitaxel as in arm I. Treatment in both arms repeats every 21 days for 6 to 10 courses in the absence of disease progression or unacceptable toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052468
|Herlev Hospital - University Hospital of Copenhagen|
|Copenhagen, Denmark, DK2730|
|Hotel Dieu de Paris|
|Paris, France, 75181|
|Bremen, Germany, D-28205|
|Dusseldorf, Germany, DOH-40217|
|Essen, Germany, D-45122|
|Staedtische Kliniken Frankfurt am Main - Hoechst|
|Frankfurt, Germany, D-65929|
|Frauenklinik der MHH|
|Hannover, Germany, 30659|
|Karlsruhe, Germany, D-76137|
|University Hospital Schleswig-Holstein - Kiel Campus|
|Kiel, Germany, D-24105|
|Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg|
|Magdeburg, Germany, 39108|
|Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster|
|Muenster, Germany, D-48129|
|Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen|
|Munich, Germany, D-81377|
|Klinikum Rechts Der Isar - Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Tuebingen, Germany, D-72076|
|Ulm, Germany, D-89075|
|Wiesbaden, Germany, D-65199|
|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|