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Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Clinical research trials and Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer. Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer  Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
For Condition: stage 3 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,stage 2 ovarian epithelial cancer,Fallopian Tube Cancer,peritoneal cavity cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada , European Organization for Research and Treatment of Cancer
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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known which combination chemotherapyregimen is more effective in treating ovarian epithelial, primaryperitoneal, or fallopian tube cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer.
Details: OBJECTIVES: - Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin vs paclitaxel and carboplatin only, in terms of time to disease progression, in patients with newly diagnosed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. - Compare the overall survival of patients treated with these regimens. - Compare the clinical objective response rates in patients with measurable disease at baseline treated with these regimens. - Compare the toxic effects of these regimens in these patients. - Compare the CA 125 normalization rates in patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (65 years and under vs over 65 years), and pre-randomization surgery (no debulking vs debulking with macroscopic residual disease less than 1 cm vs debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic residual disease). Patients are randomized to one of two treatment arms. - Arm I: Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30 minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 5-8. - Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 1-8. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Planned interval debulking surgery should occur after course 3 or 4. Quality of life is assessed at baseline; on day 1 of courses 3, 5, and 7; at the end of the last course; and at 3 and 6 months after study treatment completion. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer - No borderline ovarian tumors - Residual disease allowed - Fine needle aspiration showing an adenocarcinoma is allowed instead of open or true-cut biopsy if the following are true: - Presence of pelvic mass AND - Omental cake or other metastasis larger than 2 cm in the upper abdomen unless proven stage IV disease AND - Serum CA 125/carcinoembryonic antigen ratio at least 25 (if less than 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for primary tumor within 6 weeks of study) AND - Normal mammography within 6 weeks of study PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - ECOG 0-1 Life expectancy: - At least 12 weeks Hematopoietic: - Granulocyte count at least 2,000/mm^3 - Platelet count at least 150,000/mm^3 Hepatic: - Not specified Renal: - Creatinine no greater than upper limit of normal Cardiovascular: - No clinically relevant atrial or ventricular arrhythmias - No myocardial infarction (MI) within the past 6 months (pretreatment ECG as only evidence of MI allowed) - No history of second- or third-degree heart blocks unless pacemaker implanted - History of first-degree heart block allowed Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No complete bowel obstruction - No prior allergic reaction to drugs containing Cremophor EL or compounds chemically related to study drugs - No condition that would preclude high-volume saline diuresis - No significant neurologic or psychiatric disorder that would preclude study compliance - No active uncontrolled infection - No neuropathy greater than grade 1 - No pre-existing hearing loss greater than grade 1 - No other concurrent serious illness or medical condition that would preclude study participation - No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent biological response modifiers or immunotherapy - No concurrent prophylactic colony-stimulating factors (CSFs) - Concurrent therapeutic CSFs allowed Chemotherapy: - No prior chemotherapy for ovarian cancer - No other concurrent cytotoxic agents Endocrine therapy: - No concurrent anticancer hormonal therapy Radiotherapy: - No prior radiotherapy for ovarian cancer Surgery: - No more than 6 weeks since prior planned pre-chemotherapy surgery for ovarian cancer - Planned interval debulking allowed - Concurrent second-look surgery allowed Other: - No prior non-surgical therapy for ovarian cancer - No other concurrent investigational drug therapy - No other concurrent anticancer treatment - Concurrent enrollment on CAN-NCIC-OV13/EORTC 55971 allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IgnaceVergote, , U.Z. Gasthuisberg
Hospital Universitario Miguel Servet *Recruiting*
Zaragoza, , 50009
Spain
Recruiting Contact Person 34-976-765-500
Hospital Universitario 12 de Octubre *Recruiting*
Madrid, , 28041
Spain
Recruiting Contact Person 34-93-390-8003
Hotel Dieu Health Sciences Hospital - Niagara *Recruiting*
St. Catharines, Ontario, L2R 5K3
Canada
Recruiting Brian Findlay 905-682-6451
Fraser Valley Cancer Centre at British Columbia Cancer Agency *Recruiting*
Surrey, British Columbia, V3V 1Z2
Canada
Recruiting Lee Martin 604-930-4028
Hospitais da Universidade de Coimbra (HUC) *Recruiting*
Coimbra, , 3049
Portugal
Recruiting Contact Person 351-239-403-939
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Prafull Ghatage 403-944-1721
Hospital Clinic y Provincial de Barcelona *Recruiting*
Barcelona, , 08036
Spain
Recruiting Contact Person 34-93-227-5400
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting Peter Bryson 613-548-6071
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
Instituto Valenciano De Oncologia *Recruiting*
Valencia, , 46009
Spain
Recruiting Contact Person 34-96-349-3411
Centre Hospitalier Universitaire de Quebec *Recruiting*
Quebec City, Quebec, G1R 2J6
Canada
Recruiting Marie Plante 418-691-5392
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Alexandra Schepansky 780-432-8560
Hospital Universitario LA FE *Recruiting*
Valencia, , 46009
Spain
Recruiting Contact Person 34-96-386-2700
Institut Catala D'Oncologia *Recruiting*
Barcelona, , 08907
Spain
Recruiting Contact Person 34-93-335-7652
Kaiser Franz Josef Hospital *Recruiting*
Vienna, , A-1100
Austria
Recruiting Contact Person 43-1-601-9152
Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay, Ontario, P7B 6V4
Canada
Recruiting Susan Huan 807-684-7200
Hospital Universarito "Reina Sofia" *Recruiting*
Cordoba, , 14004
Spain
Recruiting Contact Person 34-957-010-001
Hopital Du Sacre-Coeur de Montreal *Recruiting*
Montreal, Quebec, H4J 1C5
Canada
Recruiting Josee-Anne Roy 514-338-2050
Hospital Sant Joan de Reus *Recruiting*
Reus (Tarragona), , 43201
Spain
Recruiting Contact Person 34-977-310-300
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R3E 0V9
Canada
Recruiting Robert Lotocki 204-787-1937
Lions Gate Hospital *Recruiting*
North Vancouver, British Columbia, V7L 2P9
Canada
Recruiting Paul Klimo 604-984-5753
Hospital Universitario Puerta Del Mar *Recruiting*
Cadiz, , 11000
Spain
Recruiting Contact Person 34-956-242-100
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Tien Le 613-737-8560
Prince Edward Island Cancer Center at Queen Elizabeth Hospital *Recruiting*
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Recruiting Dagny Dryer 902-894-2027
Ospedale Mauriziano Umberto I *Recruiting*
Torino, , 10128
Italy
Recruiting Contact Person 39-11-508-1111
Grand River Regional Cancer Centre *Recruiting*
Kitchner, Ontario, N2G 1G3
Canada
Recruiting Carolyn Campbell 519-749-4370
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital *Recruiting*
Nanaimo, British Columbia, V9S 2B7
Canada
Recruiting Christopher Williams 250-716-7706
CHUS-Hopital Fleurimont *Recruiting*
Fleurimont, Quebec, J1H 5N4
Canada
Recruiting Paul Bessette 819-346-1110 Ext. 14317
Nova Scotia Cancer Centre *Recruiting*
Halifax, Nova Scotia, B3H 1V7
Canada
Recruiting Robert Grimshaw 902-473-4029
Hospital Clinico Universitario de Valencia *Recruiting*
Valencia, , 46010
Spain
Recruiting Contact Person 34-96-386-2600
Hospital General Universitario Valencia *Recruiting*
Valencia, , 46014
Spain
Recruiting Contact Person 34-96-386-2900
Hospital Son Dureta *Recruiting*
Palma de Mallorca, , 07014
Spain
Recruiting Contact Person 34-971-175-000
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-33-2211
Durham Regional Cancer Centre at Lakeridge Health Oshawa *Recruiting*
Oshawa, Ontario, L1G 2B9
Canada
Recruiting Jose Chang 905-576-8711 ext. 4298
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-3-821-3000
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Haji Chalchal 306-766-2691
Moncton Hospital *Recruiting*
Moncton, New Brunswick, E1C 6ZB
Canada
Recruiting Sheldon Rubin 506-857-2881
Hospital Universitari Germans Trias i Pujol *Recruiting*
Badalona, , 08916
Spain
Recruiting Contact Person 34-93-497-8925
Cazk Groeninghe - Campus Maria's Voorzienigheid *Recruiting*
Kortrijk, , B-8500
Belgium
Recruiting Contact Person 32-56-234-211
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Mark Carey 519-685-8273
Hospital de la Santa Cruz I Sant Pau *Recruiting*
Barcelona, , 08025
Spain
Recruiting Contact Person 34-3-473-133
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Laurie Elit 905-389-5688
Hopital Notre- Dame du CHUM *Recruiting*
Montreal, Quebec, H4L 2M1
Canada
Recruiting Diane Provencher 514-890-8200 ext. 27244
Cancer Care Ontario - Windsor Regional Cancer Centre *Recruiting*
Windsor, Ontario, N8W 2X3
Canada
Recruiting Sam Yoshida 519-253-3191 Ext. 58504
H. Hartziekenhuis V.Z.W. *Recruiting*
Roeselare, , 8800
Belgium
Recruiting Contact Person 32-51-23-7111
Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese, , 21100
Italy
Recruiting Contact Person 32-332-278-111
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Paul Hoskins 604-877-6000 Ext. 2365
Hospital Universitario San Carlos *Recruiting*
Madrid, , 28041
Spain
Recruiting Contact Person 34-1-330-3000
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Amit Oza 416-946-2818
British Columbia Cancer Agency - Centre for the Southern Interior *Recruiting*
Kelowna, British Columbia, V1Y 5L3
Canada
Recruiting Marianne Taylor 250-712-3996
Northeastern Ontario Regional Cancer Centre - Sudbury *Recruiting*
Sudbury, Ontario, P3E 5J1
Canada
Recruiting Colin Germond 705-523-6237 ext. 2320
Saskatoon Cancer Centre *Recruiting*
Saskatoon, Saskatchewan, S7N 4H4
Canada
Recruiting David Popkin 306-655-2684
Additional Information:
Study ID Numbers: CDR0000069129; EORTC-55012,CAN-NCIC-OV16,GEICO-0101
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028743
Other Stage 2 Ovarian Epithelial Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
2. Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
3. Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer
4. Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
5. BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Related Studies:
Other stage 2 ovarian epithelial cancer Clinical Trials
Other Clinical Trials
Other Valencia Clinical Trials
Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
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