A Randomized Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) Versus Paclitaxel/Carboplatin (TC) in the Treatment of Women With Advanced Ovarian Cancer
carboplatin
+ epirubicin hydrochloride
+ paclitaxel
Urogenital Diseases+18
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: August 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Compare progression free survival and overall survival in patients with stage IIB, III, or IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer treated with paclitaxel and carboplatin with or without epirubicin. Compare the toxicity of these 2 regimens in these patients. Compare the quality of life of patients treated with these 2 regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and type of surgery (delayed surgery: 3 courses of chemotherapy before surgery vs primary surgery: optimally debulked stage IIB or III [residual tumor less than 1 cm] vs primary surgery: suboptimally debulked stage IV [residual tumor 1 cm or greater]). Surgery Patients are assigned to one of two surgery groups: Group A: Patients undergo primary surgery comprised of hysterectomy, bilateral salpingo-oophorectomy (BSO), omentectomy, and resection of all tumor masses, if possible, before beginning chemotherapy. Patients with residual disease greater than 1 cm after completion of primary surgery receive 3 courses of chemotherapy, followed within 6 weeks by interval debulking surgery, followed within 3 weeks by the fourth course of chemotherapy. Group B: Patients undergo delayed surgery comprised of hysterectomy, BSO, omentectomy, and resection of all tumor masses, if possible, after completion of 3 courses of chemotherapy. Chemotherapy Patients are randomized to 1 of 2 chemotherapy arms: Arm I: Patients receive epirubicin IV over 15-20 minutes, paclitaxel IV over 3 hours, and carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients with residual tumor after completion of 6 courses may receive 3 additional courses. Arm II: Patients receive paclitaxel and carboplatin as above but no epirubicin. Quality of life is assessed before beginning study, after completion of courses 3, 6, and 9 (if applicable), and then at 6 and 12 months after completion of study treatment. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven stage IIB, III, or IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer No symptomatic brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO/ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2 times upper limit of normal Renal: Glomerular filtration rate at least 50 mL/min Cardiovascular: No ventricular arrhythmia (LOWN class II or worse) No myocardial infarction within the past year No severe or uncontrolled hypertension No history of congestive heart disease (no New York Heart Association class III or IV heart disease) even if medically controlled LVEF at least 50% Other: No other primary malignancies except carcinoma in situ of the cervix or basal cell skin cancer No worse than grade I preexisting motor or sensory neurologic pathology or symptoms No active infection or other serious underlying medical condition that would prevent compliance Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent antineoplastic agents Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 18 locations
St. Mary's/Duluth Clinic Cancer Center
Duluth, United StatesOpen St. Mary's/Duluth Clinic Cancer Center in Google MapsU.Z. Gasthuisberg
Leuven, BelgiumTom Baker Cancer Center - Calgary
Calgary, CanadaCancerCare Manitoba
Winnipeg, Canada