Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer (AGO-OVAR9)
Fallopian Tube Cancer, Ovarian Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of one of the following: Ovarian epithelial cancer FIGO stage IA/B G3, IC-IV Fallopian tube cancer Extra-ovarian papillary serous tumor The following are ineligible: Low malignant-potential ovarian tumors (borderline tumors) Non-epithelial ovarian tumors Mixed Mullerian tumors Must have had definitive surgery within the past 6 weeks No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic WBC at least 3,000/mm^3 OR Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin greater than 10 mg/dL Hepatic Bilirubin no greater than 2 times upper limit of normal Renal Glomerular filtration rate at least 50 mL/min Cardiovascular No congestive heart failure No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No prior atrial or ventricular arrhythmias Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior seizures or central nervous system disorder No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K) No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel No preexisting motor or sensory neuropathy greater than grade 1 No other malignancy within the past 5 years except: Malignancies cured by surgery alone Carcinoma in situ of the cervix Adequately treated basal cell skin cancer No complete bowel obstruction No other concurrent severe medical condition that would preclude study participation No dementia or significantly altered mental status that would preclude study participation No concurrent severe active infection Geographically accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy No prior chemotherapy No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy except: Hormone replacement therapy Antiemetic steroids Radiotherapy No prior radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics Recovered from prior surgery Other No other concurrent antineoplastic agents No other concurrent investigational drugs No other concurrent clinical trial enrollment
Sites / Locations
- Herlev Hospital - University Hospital of Copenhagen
- Hotel Dieu de Paris
- Zentralkrankenhaus
- Evangelisches Krankenhaus
- Universitaetsklinikum Essen
- Staedtische Kliniken Frankfurt am Main - Hoechst
- Frauenklinik der MHH
- Vincentius Krankenhaus
- University Hospital Schleswig-Holstein - Kiel Campus
- Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
- Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster
- Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
- Universitaetsklinikum Tuebingen
- Universitaet Ulm
- Dr. Horst-Schmidt-Kliniken
- Norwegian Radium Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
TCG
TC
Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses
Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses