Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, recurrent fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer, recurrent primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer
Eligibility 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
Sites / Locations
- Charite University Hospital - Campus Virchow KlinikumRecruiting
- Krankenhaus NordwestRecruiting
- University Medical Center Hamburg - EppendorfRecruiting
- Universitaets - Kinderklinik - LuebeckRecruiting
- Kreiskrankenhaus TrostbergRecruiting
- Peterfy Korhaz Szulo-Nobeteg OztalyRecruiting
- Academisch Medisch Centrum at University of AmsterdamRecruiting