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A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer

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Trial Information

A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Tumor response

Safety Issue:

No

Principal Investigator

Joan M.C. Bull, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The University of Texas Health Science Center, Houston

Authority:

Unspecified

Study ID:

CDR0000065903

NCT ID:

NCT00003135

Start Date:

November 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • 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
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Fever
  • Ovarian Neoplasms
  • Adenoma

Name

Location
University of Texas Health Science Center at Houston Houston, Texas  77225