Expired Study
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Houston, Texas 77225


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

CDR0000065903


NCT ID:

NCT00003135


Secondary ID:

UTHSC-MS-96205


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

Unspecified


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

34


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:November 1997
Primary Completion Date:September 2009
Primary Completion Type:Anticipated
Verification Date:December 2008
Last Changed Date:April 29, 2009
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Tumor response
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Toxicity
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:fluorouracil
Intervention Type:Drug
Name:pegylated liposomal doxorubicin hydrochloride
Intervention Type:Procedure
Name:hyperthermia treatment

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The University of Texas Health Science Center, Houston

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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