A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy
- 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
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
Joan M.C. Bull, MD
The University of Texas Health Science Center, Houston
|University of Texas Health Science Center at Houston||Houston, Texas 77225|