Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer

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

Summary

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hyperthermia may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving fluorouracil and liposomal doxorubicin together with systemic hyperthermia works in treating patients with metastatic breast, ovarian, endometrial, or cervical cancer.

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

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Doxorubicin; Fluorouracil; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic breast, ovarian, endometrial, or cervical carcinoma

• Measurable and evaluable disease

• No brain metastases

• No hepatic involvement greater than 80%

• No lung involvement greater than 30%

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Not specified

Menopausal status:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count greater than 1,500/mm^3

• Platelet count greater than 90,000/mm^3

• Normal bone marrow cellularity on bone marrow biopsy

• Thrombin time less than 17 sec

• Fibrinogen greater than 200 mg/dL

• FSP less than 40

• No coagulopathy

Hepatic:

• Bilirubin less than 2.0 mg/dL

• SGPT less than 2 times normal

• PT less than 14 sec

• PTT less than 35 sec

Renal:

• BUN less than 25 mg/dL

• Creatinine clearance at least 45 mL/min

Cardiovascular:

• Normal cardiovascular system

• Resting ventricular ejection fraction greater than 40%

• No prior myocardial infarction

• No symptomatic coronary artery disease

• No unstable blood pressure

• No thromboembolic disease

Neurologic:

• No seizures or other CNS disorders

• Negative computerized tomographic scan of brain

Pulmonary:

• FEV_1 greater than 70% of predicted

• Arterial pressure of oxygen greater than 60 mmHg on room air with appropriate pressure of carbon dioxide and pH values

• No history of cardiopulmonary or respiratory disease

Other:

• No other serious concurrent medical illness

• No diabetes mellitus

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior chemotherapy allowed

Endocrine therapy:

• No adrenal corticosteroids

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent cardiac glycosides, antianginal therapy, or antiarrhythmics

• No concurrent vasodilators, anticoagulants, thrombolytic agents, or aspirin