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Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube 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 Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer Clinical research trials and Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube 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 Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer. Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube 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 Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube 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 > Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer  Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
For Condition: Fallopian Tube Cancer,stage 3 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,stage 1 ovarian epithelial cancer,stage 2 ovarian epithelial cancer
Status: Recruiting
Sponsor(s): AGO Ovarian Cancer Study Group , Nordic Society for Gynaecologic Oncology,GERCOR
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 whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of carboplatin and paclitaxel combined with gemcitabine to that of paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.
Details: OBJECTIVES: - Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian tube cancer treated with adjuvant carboplatin and paclitaxel with or without gemcitabine. - Compare response rates, progression-free survival, and duration of response in patients treated with these regimens. - Compare toxic effects of these regimens in these patients. - Compare quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. - Arm II: Patients receive carboplatin and paclitaxel as in arm I. Treatment in both arms repeats every 21 days for 6 to 10 courses in the absence of disease progression or unacceptable toxicity. Some patients undergo interval debulking surgery. Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study. Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,192 patients (596 per treatment arm) will be accrued for this study within 1.5-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of one of the following: - Ovarian epithelial cancer - FIGO stage IA/B G3, IC-IV - Fallopian tube cancer - Extra-ovarian papillary serous tumor - The following are ineligible: - Low malignant-potential ovarian tumors (borderline tumors) - Non-epithelial ovarian tumors - Mixed Mullerian tumors - Must have had definitive surgery within the past 6 weeks - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - WBC at least 3,000/mm OR - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin greater than 10 mg/dL Hepatic - Bilirubin no greater than 2 times upper limit of normal Renal - Glomerular filtration rate at least 50 mL/min Cardiovascular - No congestive heart failure - No myocardial infarction within the past 6 months - No New York Heart Association class III or IV heart disease - No prior atrial or ventricular arrhythmias Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior seizures or central nervous system disorder - No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K) - No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel - No preexisting motor or sensory neuropathy greater than grade 1 - No other malignancy within the past 5 years except: - Malignancies cured by surgery alone - Carcinoma in situ of the cervix - Adequately treated basal cell skin cancer - No complete bowel obstruction - No other concurrent severe medical condition that would preclude study participation - No dementia or significantly altered mental status that would preclude study participation - No concurrent severe active infection - Geographically accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy Chemotherapy - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy except: - Hormone replacement therapy - Antiemetic steroids Radiotherapy - No prior radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics - Recovered from prior surgery Other - No other concurrent antineoplastic agents - No other concurrent investigational drugs - No other concurrent clinical trial enrollment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
E.Pujade-Lauraine, Study Chair, Hotel Dieu de Paris
Universitaetsklinikum Essen *Recruiting*
ESSEN, , D-45122
Germany
Recruiting Rainer Kimmig 49-201-723-2440
Vincentius Krankenhaus *Recruiting*
Karlsruhe, , D-76137
Germany
Recruiting Anne Stahle 49-721-8108-3664
Zentralkrankenhaus *Recruiting*
Bremen, , D-28205
Germany
Recruiting Willibald Schroder 49-421-497-5351
Staedtische Kliniken Frankfurt am Main - Hoechst *Recruiting*
Frankfurt, , D-65929
Germany
Recruiting Volker Moebus 069-3106-2339
Frauenklinik der MHH *Recruiting*
Hannover, , 30659
Germany
Recruiting Hans-Joachim Lueck 49-511-906-3705
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Gunnar Kristensen 47-22-934-000
Universitaetsklinikum Tuebingen *Recruiting*
Tuebingen, , D-72076
Germany
Recruiting Uwe Wagner 49-7071-298-2246
Medizinische Klinik I *Recruiting*
Dresden, , D-01307
Germany
Recruiting Barbara Richter 49-351-458-3420
Klinik und Poliklinik fuer Kinderheilkunde *Recruiting*
Muenster, , D-48129
Germany
Recruiting Christian Jackisch 49-251-834-8108
Klinik der Otto - v. - Guericke - Universitat *Recruiting*
Magdeburg, , 39108
Germany
Recruiting Sigrid Olbricht 49-391-6717-386
Evangelisches Krankenhaus *Recruiting*
Dusseldorf, , DOH-40217
Germany
Recruiting Werner Meier 49-211-919-1405
Universitaet Ulm *Recruiting*
Ulm, , D-89075
Germany
Recruiting V. Heilmann 0731 / 502 7621
University Hospital Schleswig-Holstein - Kiel Campus *Recruiting*
Kiel, , D-24105
Germany
Recruiting Jacobus Pfisterer 49-431-597-4089
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen *Recruiting*
Munich, , D-81377
Germany
Recruiting Alexander Burges 49-7095-25-50
Herlev Hospital - University Hospital of Copenhagen *Recruiting*
Copenhagen, , DK2730
Denmark
Recruiting J. Herrstedt 45-44-88-3499
Dr. Horst-Schmidt-Kliniken *Recruiting*
Wiesbaden, , D-65199
Germany
Recruiting Andreas Bois 49-611-43-23-77
Klinikum Rechts Der Isar - Technische Universitaet Muenchen *Recruiting*
Munich, , D-81675
Germany
Recruiting Barbara Schmalfeldt 089-4140-2437
Hotel Dieu de Paris *Recruiting*
Paris, , 75181
France
Recruiting E. Pujade-Lauraine 33-1-42-34-82-22
Additional Information:
Study ID Numbers: CDR0000258429; EU-20241,GERCOR-AGO-OVAR-9,NORDIC-AGO-OVAR-9,AGO-OVAR-9
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052468
Other Stage 4 Ovarian Epithelial Cancer Studies:
1. Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
2. Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
3. Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer
4. Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
5. Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
Related Studies:
Other stage 4 ovarian epithelial cancer Clinical Trials
Other Clinical Trials
Other Hannover Clinical Trials
Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
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