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

The University of Texas System (UT)

Status and phase

Unknown

Phase 2

Conditions

Endometrial Cancer

Breast Cancer

Ovarian Cancer

Cervical Cancer

Treatments

Procedure: hyperthermia treatment

Drug: fluorouracil

Drug: pegylated liposomal doxorubicin hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00003135

CDR0000065903

UTHSC-MS-96205

NCI-V97-1356

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: