search
Back to results

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

Primary Purpose

Breast Cancer, Cervical Cancer, Endometrial Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fluorouracil
pegylated liposomal doxorubicin hydrochloride
hyperthermia treatment
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Science Center at HoustonRecruiting

Outcomes

Primary Outcome Measures

Tumor response
Toxicity

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
April 29, 2009
Sponsor
The University of Texas Health Science Center, Houston
search

1. Study Identification

Unique Protocol Identification Number
NCT00003135
Brief Title
Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
Official Title
A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 1997 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride
Intervention Type
Procedure
Intervention Name(s)
hyperthermia treatment
Primary Outcome Measure Information:
Title
Tumor response
Title
Toxicity

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan M.C. Bull, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan M.C. Bull, MD
Phone
713-500-6820
Email
joan.m.bull@uth.tmc.edu

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs