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High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery Clinical research trials and High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery health trials happen in many 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 measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery. High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery clinical trial. Human subjects often get the best healthcare available for their High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery  High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery
High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery
For Condition: stage 4 ovarian epithelial cancer,stage 3 ovarian epithelial cancer
Status: Recruiting
Sponsor(s): EBMT Solid Tumors Working Party ,
Synopsis: 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 which chemotherapy regimen is most effective for ovarian epithelial cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of high-dose chemotherapy with that of standard chemotherapy in treating patients who have stage III or stage IV ovarian epithelial cancer that has been removed during surgery.
Details: OBJECTIVES: - Compare the two-year progression-free survival in patients with optimally debulked stage III or IV ovarian epithelial cancer undergoing high-dose sequential chemotherapy vs standard chemotherapy. - Compare the overall survival, toxicity, and quality of life in this patient population receiving these two treatment regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Patients receive 5 courses of sequential high-dose chemotherapy as follows: - Courses 1 and 2: Patients receive paclitaxel IV over 3 hours and cyclophosphamide IV over 2 hours on day 1 followed by peripheral blood stem cell (PBSC) collection. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours following chemotherapy and continuing until target number of PBSC are reached. - Courses 3 and 4: Patients receive paclitaxel as in courses 1-2 and carboplatin IV over 4 hours on day 1. At 72 hours following completion of carboplatin, patients receive PBSC infusion. Beginning one day following PBSC infusion, patients receive G-CSF SC until blood counts recover. - Course 5: Patients receive paclitaxel as in courses 1 and 2 and carboplatin as in courses 3 and 4 and melphalan IV over 15 minutes on day 2 or 3. Patients receive PBSC and G-CSF as in courses 3 and 4. - Treatment repeats every 3-4 weeks. - Arm II: Patients receive standard chemotherapy consisting of carboplatin (or cisplatin) and paclitaxel IV over 3 hours every 3 weeks for 6 courses. Patients may receive doxorubicin or epirubicin in addition to the standard chemotherapy every 4 weeks. Quality of life is assessed prior to therapy, at 4-6 weeks following completion of therapy, and then at 3 months, 9 months, and 15 months. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 208 patients (104 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage III or IV ovarian epithelial cancer - Bilateral salpingo-oophorectomy, hysterectomy, and omentectomy within 6 weeks of study - Less than 2 cm maximum diameter of residual tumor remaining PATIENT CHARACTERISTICS: Age: - 18 to 65 Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Normal hematological function Hepatic: - Normal hepatic function Renal: - Creatinine clearance greater than 60 mL/min - GFR greater than 60 mL/min Cardiovascular: - No active cardiac disease Other: - No other uncontrolled serious medical illness, including hearing problems - No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonathanLedermann, Study Chair, Cancer Research UK and University College London Cancer Trials Unit
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Tim Perren 44-113-206-4670
Staedt Klinikum Karlsruhe GGMBH *Recruiting*
Karlsruhe, , 76133
Germany
Recruiting Joerg Fischer 49-721-974-3001
Thomayer Memorial Teaching Hospital *Recruiting*
Prague 4, , 14000
Czech Republic
Recruiting J Nepomuca 42-2-4701
National Cancer Institute - Bratislava *Recruiting*
Bratislava, , 833 10
Slovakia
Recruiting J. Lakota 00421-25937811
Ospedale Santa Chiara *Recruiting*
Pisa, , 56100
Italy
Recruiting C Bengala 39-050-992929
Charles University *Recruiting*
Prague 10, , 10034
Czech Republic
Recruiting T. Kozak 420-26-716-2292
Klinikum Nuernberg - Klinikum Nord *Recruiting*
Nuernberg, , D-90419
Germany
Recruiting Hannes Wandt 49-911-398-3060
Hospital Clinico Universitario de Valencia *Recruiting*
Valencia, , 46010
Spain
Recruiting Javier Garcia-Conde 34-96-386-2625
Centre Hospitalier Notre Dame - Reine Fabiola *Recruiting*
Charleroi, , 6000
Belgium
Recruiting Jean-Luc Canon 32-71-281666
Ospedale San Bortolo *Recruiting*
Vicenza, , 36100
Italy
Recruiting L. Merlini 39-0444-993-906
Hospital Universitario San Carlos *Recruiting*
Madrid, , 28040
Spain
Recruiting Antonio Herraez 34-91-330-3546
Sozialmedizinisches Zentrum Ost - Donauspital *Recruiting*
Vienna, , A-1220
Austria
Recruiting R Ruckser 43-1-28802
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi *Recruiting*
Bologna, , 40138
Italy
Recruiting C Zamagni 39-051-636-2206
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Jean Bauer 41-21-314-0169
Cancer Research UK and University College London Cancer Trials Unit *Recruiting*
London, England, NW1 2ND
United Kingdom
Recruiting Jonathan Ledermann 44-20-7679-8040
S. Camillo Hospital *Recruiting*
Rome, , 00152
Italy
Recruiting L Rosal +39-0658704301
Weston Park Hospital *Recruiting*
Manchester, England, M20 9BX
United Kingdom
Recruiting Paul Lorigan 44-161-446-3000
Additional Information:
Study ID Numbers: CDR0000067604; EBMT-HIDOC-EIS,EBMT-OVCAT,EU-99040
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004921
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Genetic Study in Patients with Advanced Epithelial Ovarian Cancer
2. Vaccine Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
3. National Ovarian Cancer Early Detection Program Screening and Genetic Study
4. Pertuzumab in Treating Patients With Advanced Refractory or Recurrent Ovarian Cancer
5. Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
Related Studies:
Other stage 3 ovarian epithelial cancer Clinical Trials
Other Clinical Trials
Other Madrid Clinical Trials
High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery
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