A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy
fluorouracil
+ pegylated liposomal doxorubicin hydrochloride
+ hyperthermia treatment
Urogenital Diseases+26
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: November 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.34 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas Health Science Center at Houston
Houston, United StatesOpen University of Texas Health Science Center at Houston in Google Maps