Breast Cancer Clinical Trial
Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
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.
Full Description
OBJECTIVES:
Evaluate tumor response and toxicity induced by fluorouracil and doxorubicin HCl liposome combined with mild systemic hyperthermia in patients with metastatic breast, ovarian, endometrial, or cervical cancer.
OUTLINE: This is a time-escalation study of systemic hyperthermia.
Patients receive fluorouracil IV continuously over 24 hours on days 1-5 and doxorubicin HCl liposome IV over 30 minutes on day 6. Beginning on day 7, patients receive heat applied for 6-24 hours (in 6-hour sequential treatments) using a mild hyperthermia-induction device. Treatment repeats every 4-5 weeks for a total of 4 courses. Patients who achieve less than a complete response but have no disease progression may receive additional courses of chemotherapy alone.
Cohorts of 5 patients receive escalating durations of hyperthermia until the recommended phase II duration is determined. The recommended phase II duration of hyperthermia is defined as the level preceding that at which 1 of 5 patients experiences measurable toxicity. (Phase I closed as of 9/28/01)
Patients are followed at 4 weeks and then every 6 months for 1 year.
PROJECTED ACCRUAL: A maximum of 34 patients will be accrued for this study within 48 months.
Eligibility 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
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