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
Maladies génito-urinaires+26
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 1997
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.34 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
University of Texas Health Science Center at Houston
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