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

Study Description

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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

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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

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Tumor response
2. Toxicity

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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