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Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical research trials and Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer. Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer  Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
For Condition: stage 2 ovarian epithelial cancer,peritoneal cavity cancer,stage 3 ovarian epithelial cancer,Fallopian Tube Cancer,stage 4 ovarian epithelial cancer
Status: Completed
Sponsor(s): Nordic Society for Gynaecologic Oncology , EORTC Gynecological Cancer Cooperative Group,National Cancer Institute of Canada
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether receiving paclitaxel and carboplatin with epirubicin is more effective than paclitaxel and carboplatin alone for ovarian epithelial, fallopian tube, or peritoneal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin with or without epirubicin in treating patients who have stage IIB, stage III, or stage IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GunnarKristensen, Study Chair, Norwegian Radium Hospital
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , 3049
Portugal
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Shaare Zedek Medical Center
Jerusalem, , 91031
Israel
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Ospedale di Circolo e Fondazione Macchi
Varese, , 21100
Italy
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Spedali Civili
Brescia, , 25123
Italy
Aalborg Hospital
Aalborg, , 9100
Denmark
Medisch Spectrum Twente
ENSCHEDE, , 7500 KA
Netherlands
Institut d'Oncologia Corachan
Barcelona, , 08.017
Spain
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
St. Mary's/Duluth Clinic Cancer Center
Duluth, Minnesota, 55805
United States
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
Lisbon, , 1099-023 Codex
Portugal
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Odense University Hospital
Odense, , DK-5000
Denmark
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), , 20133
Italy
Additional Information:
Study ID Numbers: CDR0000067620; NSGO-OC9804,CAN-NCIC-OV14,EORTC-55981
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004934
Other Peritoneal Cavity Cancer Studies:
1. BMS-247550 in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
2. Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
3. Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
4. Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
5. Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
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Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
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