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Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer Clinical research trials and Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer. Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer  Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer
Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer
For Condition: stage 3 ovarian epithelial cancer,Fallopian Tube Cancer,stage 2 ovarian epithelial cancer,stage 4 ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): AGO Ovarian Cancer Study Group ,
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 if paclitaxel plus carboplatin is more effective with or without topotecan for ovarian epithelial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel plus carboplatin with or without topotecan in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer.
Details: OBJECTIVES: I. Compare survival of patients with stage IIB, III, or IV ovarian epithelial carcinoma after receiving treatment with paclitaxel and carboplatin with or without topotecan. II. Compare progression-free survival of these patients after receiving these treatment regimens. III. Compare the response rate and response duration in these patients treated with these regimens. IV. Determine the toxic effects of the combination of paclitaxel, carboplatin, and topotecan in these patients. V. Compare the toxic effects of these treatment regimens in these patients. VI. Compare quality of life of these patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and stage (stage IIB and stage III optimally debulked to no greater than 1 cm residual tumor vs stage IV regardless of residual tumor or residual tumor greater than 1 cm). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 0.5-1 hour on day 1 and topotecan IV over 0.5 hour on days 1-5. Treatment repeats every 21 days for 6 courses (topotecan is administered for 4 courses only). Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment repeats every 21 days for 6 courses. Quality of life is assessed before courses 1, 3, and 5 and at 3 weeks and 3 months after completion of treatment in both treatment arms; before courses 1 and 3 of topotecan in arm I; and at 6 months after completion of treatment in arm II. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 914 patients (457 per treatment arm) will be accrued for this study over 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage IIB, III, or IV ovarian epithelial carcinoma, fallopian tube, or extraovarian papillary serous carcinoma extending to the ovary; No mixed epithelial/non-epithelial tumors (e.g., mixed Mullerian tumors); No tumors of low malignant potential (e.g., borderline tumors) - No symptomatic brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy; No concurrent WBC transfusions - Chemotherapy: No prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy - Radiotherapy: No prior radiotherapy; No concurrent radiotherapy - Surgery: No more than 6 weeks since prior definitive laparotomy and recovered - Other: No other concurrent antineoplastic agents; No other concurrent investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 OR Karnofsky 70-100% - Life expectancy: More than 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times the upper limit of normal (ULN); Alkaline phosphatase no greater than 3 times ULN - Renal: Creatinine no greater than 1.25 times ULN; Estimated glomerular filtration rate at least 60 mL/min - Cardiovascular: No history of congestive heart failure (even if medically controlled); No New York Heart Association class III or IV heart disease; No myocardial infarction within the past 6 months; No history of atrial or ventricular arrhythmias - Other: No motor or sensory neurologic pathology or symptoms greater than grade 1; No active infection or other serious medical condition that would preclude study; No prior allergy to drug containing Cremophor EL; No dementia or significantly altered mental state that would preclude informed consent; No complete bowel obstruction; No other prior malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JacobusPfisterer, Study Chair, AGO Ovarian Cancer Study Group
Universitaetsklinik Duesseldorf
Duesseldorf, , D-40225
Germany
Universitaetsklinikum Tuebingen
Tuebingen, , D-72076
Germany
Universitaetsklinikum Charite
Berlin, , D-10117
Germany
Christian-Albrechts University of Kiel
Kiel, , D-24105
Germany
Vincentius Krankenhaus
Karlsruhe, , D-76137
Germany
Frauenklinik der MHH
Hannover, , 30659
Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden, , D-65199
Germany
Stadtische Kliniken Frankfurt-Hochst
Frankfurt, , DOH-6-5929
Germany
Zentralkrankenhaus
Bremen, , D-28205
Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , D-60590
Germany
Universitaetskliniken Bonn
Bonn, , D-53105
Germany
Universitaetsklinik Goettingen
Gottingen, , D-37075
Germany
Klinikum Grosshadern
Munich, , D-81377
Germany
Medizinische Klinik I
Dresden, , D-01307
Germany
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich, , D-81675
Germany
Evangelisches Krankenhaus
Dusseldorf, , DOH-4-0217
Germany
Klinik und Poliklinik fuer Kinderheilkunde
Muenster, , D-48129
Germany
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , D-17487
Germany
Klinik der Otto-v.-Guericke-Universitat
Magdeburg, , 39108
Germany
Additional Information:
Study ID Numbers: CDR0000067994; NCI-V00-1602,AGOSG-OVAR-7
Study Start Date: December 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006454
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer
2. A clinical efficacy study of an oral tyrosine kinase inhibitor of VEGFR-2 to treat recurrent or persistent small-volume epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer
3. Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
4. Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
5. Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Related Studies:
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Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer
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