- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003135
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
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.
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77225
- Recruiting
- University of Texas Health Science Center at Houston
-
Contact:
- Joan M.C. Bull, MD
- Phone Number: 713-500-6820
- Email: joan.m.bull@uth.tmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Tumor response
|
Collaborators and Investigators
Investigators
- Study Chair: Joan M.C. Bull, MD, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV breast cancer
- recurrent breast cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- male breast cancer
- stage IV endometrial carcinoma
- recurrent endometrial carcinoma
- stage IVA cervical cancer
- recurrent cervical cancer
- stage IVB cervical cancer
- recurrent ovarian germ cell tumor
- stage IV ovarian germ cell tumor
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Wounds and Injuries
- Breast Diseases
- Body Temperature Changes
- Heat Stress Disorders
- Uterine Cervical Neoplasms
- Breast Neoplasms
- Endometrial Neoplasms
- Hyperthermia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Fluorouracil
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- CDR0000065903
- UTHSC-MS-96205
- NCI-V97-1356
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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