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Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer. Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer  Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
For Condition: peritoneal cavity cancer,stage 2 ovarian epithelial cancer,stage 1 ovarian epithelial cancer,stage 3 ovarian epithelial cancer,Fallopian Tube 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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.
Details: OBJECTIVES: I. Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma. II. Determine the response rate of patients treated with this regimen. III. Determine the time to progression and overall survival of patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 and 6 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma - No tumors of low-malignant potential (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 except replacement therapy or steroid antiemetics Radiotherapy: - No prior radiotherapy - No concurrent radiotherapy Surgery: No more than 6 weeks since prior definitive surgery --Patient Characteristics-- Age: 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: - WBC at least 3,000/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin greater than 10 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal Renal: Glomerular filtration rate at least 60 mL/min Cardiovascular: - No history of congestive heart failure (New York Heart Association class III or IV heart disease) even if medically controlled - No myocardial infarction within the past 6 months - No history of atrial or ventricular arrhythmias Neurologic: - No history of seizure disorder - No history of CNS disorder - No pre-existing motor or sensory neuropathy or symptoms grade 2 or greater Other: - No severe concurrent infection - No prior hypersensitivity reaction to products containing Cremophor EL or compounds chemically related to carboplatin, paclitaxel, or gemcitabine - No complete bowel obstruction - No other concurrent severe medical problems that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndreasBois, Study Chair, AGO Ovarian Cancer Study Group
Frauenklinik der MHH
Hannover, , 30659
Germany
Staedtisches Krankenhaus FFM-Hoechst
Frankfurt Am Main, , 65929
Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden, , D-65199
Germany
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , D-17487
Germany
Klinikum Grosshadern
Munich (Muenchen), , D-81377
Germany
Christian-Albrechts University of Kiel
Kiel, , D-24105
Germany
Klinik und Poliklinik fuer Kinderheilkunde
Muenster, , D-48129
Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , D-60590
Germany
Medizinische Klinik I
DRESDEN, , D-01307
Germany
Zentralkrankenhaus
Bremen, , D-28205
Germany
Klinik der Otto-v.-Guericke-Universitat
Magdeburg, , 39108
Germany
Universitaet Ulm
ULM, , D-89075
Germany
Universitaetsklinik Goettingen
Gottingen, , D-37075
Germany
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich (Muenchen), , D-81675
Germany
Universitaetsklinikum Charite
Berlin, , D-10117
Germany
Universitaetsklinikum Tuebingen
Tuebingen, , D-72076
Germany
Evangelisches Krankenhaus
Dusseldorf, , DOH-4-0217
Germany
Vincentius Krankenhaus
Karlsruhe, , D-76137
Germany
Additional Information:
Study ID Numbers: CDR0000069242; EU-20146,AGOSG-OVAR-8
Study Start Date: August 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031954
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
2. Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer
3. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
4. Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal 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 Bremen Clinical Trials
Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
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