Breast Cancer Clinical Trial
Official title:
A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy
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.
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.
;
Primary Purpose: Treatment
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