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Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical research trials and Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer medical trials happen in hundreds of localities throughout the U.S.A.. 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 does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer. Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer  Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
For Condition: peritoneal cavity cancer,recurrent ovarian epithelial cancer,Fallopian Tube Cancer
Status: Recruiting
Sponsor(s): Ludwig Maximillian Universitaet Women's Hospital ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy is more effective with or without whole-body hyperthermia therapy in treating gynecologic cancer. PURPOSE: Randomizedphase II/III trial to compare the effectiveness of chemotherapy with or without whole-body hyperthermia in treating patients who have recurrentovarian epithelial, fallopian tube, or peritoneal cancer.
Details: OBJECTIVES: - Compare the time to progressive disease in patients with recurrent ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer treated with carboplatin and ifosfamide with or without whole body hyperthermia. - Compare the response rate, duration of response, and survival time of patients treated with these regimens. - Compare the effect on the presence of disseminated tumor cells in bone marrow in patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Assess quality of life of patients treated with these regimens. OUTLINE: This is a phase II safety and efficacy study followed by a phase III randomized, open-label, multicenter study. - Phase II: Patients receive ifosfamide IV over 1 hour and carboplatin IV over 20 minutes on day 1. Patients also undergo whole body hyperthermia for at least 1 hour on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. - Patients are stratified according to disease-free interval (6-12 months vs more than 12 months), measurable disease (bidimensionally measurable vs measurable by other clinical means), and disease recurrence (first recurrence vs second or greater recurrence). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive ifosfamide, carboplatin, and whole body hyperthermia as in phase II. - Arm II: Patients receive ifosfamide and carboplatin as in arm I. - In both arms, treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before each course, 4 weeks after the last course, and then every 3 months for 2 years. Patients are followed at 4 weeks and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 15 patients will be accrued for phase II of this study. A total of 226 patients (113 per treatment arm) will be accrued for phase III of this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer - Recurrent disease (any FIGO stage) - Not amenable to curative surgery or radiotherapy alone - Failed prior primary platinum-based therapy at least 6 months after therapy discontinuation - Measurable lesion by CT scan, MRI, chest x-ray, or sonography - Physical examination allowed for documenting lymph node and skin metastases - Physical gynecological examination allowed for well-defined palpable tumor lesions - Increase in CA 125 without any measurable tumor is not acceptable as indication of recurrence - No CNS metastases - No tumor of borderline malignancy PATIENT CHARACTERISTICS: Age - 18 to 65 Performance status - ECOG 0-2 Life expectancy - At least 24 weeks Hematopoietic - Neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic - Not specified Renal - Creatinine clearance at least 60 mL/min - No chronic or acute renal failure Cardiovascular - Cardiovascular function sufficient for hyperthermia treatment by stress-ECG - No cardiomyopathy with impaired ventricular function - No New York Heart Association class III or IV heart disease - No cardiac arrhythmias influencing LVEF and requiring medication - No myocardial infarction or angina pectoris within the past 6 months - No uncontrolled arterial hypertension Pulmonary - Pulmonary function sufficient for hyperthermia treatment by pulmonary function tests Other - No untreated endocrinological disease (e.g., hyperthyroidism or diabetes mellitus) - No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer - No contraindication against hyperthermia treatment (e.g., photodermatosis, history of malignant hyperthermia, or claustrophobia) - No hypersensitivity to carboplatin, ifosfamide, or any other study medication - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No concurrent cytotoxic or other antineoplastic therapy Endocrine therapy - Concurrent hormone replacement therapy allowed - Concurrent steroid antiemetics allowed Radiotherapy - See Disease Characteristics - At least 1 year since prior radiotherapy (tumoricidal dose) of the pelvis - Concurrent palliative local radiotherapy for painful (nonprogressive) existing lesion is allowed if other measurable sites are present - No concurrent radiotherapy to a second existing lesion Surgery - See Disease Characteristics Other - No prior form of hyperthermic therapy - At least 3 weeks since other medications as part of another clinical study - At least 3 weeks since prior investigational agents - At least 6 weeks since prior betablockers - No concurrent photosensitizing drugs - No concurrent betablockers - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
H.Sommer, Study Chair, Ludwig Maximillian Universitaet Women's Hospital
Krankenhaus Nordwest *Recruiting*
Frankfurt, , D-60488
Germany
Recruiting E. Jager 49-69-7601-3380
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Anneke Westermann 31-20-566-9111
Universitaets-Krankenhaus Eppendorf *Recruiting*
Hamburg, , D-20246
Germany
Recruiting S. Hegewisch-Becker 49-40-428-033-971
Peterfy Korhaz Szulo-Nobeteg Oztaly *Recruiting*
Budapest, , 1076
Hungary
Recruiting L. Kornya 36-1-322-3450
Schwerpunkt Hamatologie Und Oncologie *Recruiting*
Berlin, , D-13353
Germany
Recruiting B. Hildebrandt 49-30-450-553-636
Universitaets - Kinderklinik *Recruiting*
Lubeck, , 23538
Germany
Recruiting A Bakhshandeh-Bath 0049-451-500-2316
Kreiskrankenhaus Trostberg *Recruiting*
Trostberg, , D-83308
Germany
Recruiting A. Biedermann 0862-11-87-5020
Additional Information:
Study ID Numbers: CDR0000256532; EU-20220,LMU-DOLPHIN-1
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045461
Other Peritoneal Cavity Cancer Studies:
1. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
2. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer
3. Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
4. Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
5. Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer
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Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
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