Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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: Randomized phase II/III trial to compare the effectiveness of chemotherapy with or without whole-body hyperthermia in treating patients who have recurrent ovarian epithelial, fallopian tube, or peritoneal cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Treatments: Carboplatin; Ifosfamide; Isophosphamide mustard

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