Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00003135

Recruitment Status : Unknown

Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting

First Posted : January 27, 2003

Last Update Posted : April 30, 2009

Sponsor:

Information provided by:

National Cancer Institute (NCI)

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer Cervical Cancer Endometrial Cancer Ovarian Cancer	Drug: fluorouracil Drug: pegylated liposomal doxorubicin hydrochloride Procedure: hyperthermia treatment	Phase 2

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 Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	34 participants
Primary Purpose:	Treatment
Official Title:	A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy
Study Start Date :	November 1997
Estimated Primary Completion Date :	September 2009

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer Ovarian cancer

MedlinePlus related topics: Cervical Cancer Fever

Drug Information available for: Fluorouracil Doxorubicin

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer Breast Cancer, Male Ovarian Germ Cell Tumor

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Tumor response
Toxicity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003135

Locations


United States, Texas
University of Texas Health Science Center at Houston	Recruiting
Houston, Texas, United States, 77225
Contact: Joan M.C. Bull, MD 713-500-6820 joan.m.bull@uth.tmc.edu

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators


Study Chair:	Joan M.C. Bull, MD	The University of Texas Health Science Center, Houston

More Information


Responsible Party:	Joan M.C. Bull, University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier:	NCT00003135 History of Changes
Other Study ID Numbers:	CDR0000065903 UTHSC-MS-96205 NCI-V97-1356
First Posted:	January 27, 2003 Key Record Dates
Last Update Posted:	April 30, 2009
Last Verified:	December 2008

Keywords provided by National Cancer Institute (NCI):


stage IV breast cancer recurrent breast cancer recurrent cervical cancer stage IVB cervical cancer stage IVA cervical cancer stage IV ovarian epithelial cancer	recurrent ovarian epithelial cancer stage IV endometrial carcinoma recurrent endometrial carcinoma stage IV ovarian germ cell tumor recurrent ovarian germ cell tumor male breast cancer

Additional relevant MeSH terms:


Breast Neoplasms Uterine Cervical Neoplasms Endometrial Neoplasms Fever Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Body Temperature Changes	Signs and Symptoms Doxorubicin Liposomal doxorubicin Fluorouracil Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

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