Clinical trial · Interventional
Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| hyperthermia treatment | Procedure | — | UNRESOLVED |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Tumor response
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available