Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
Recruitment status was: Recruiting
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.
Drug: pegylated liposomal doxorubicin hydrochloride
Procedure: hyperthermia treatment
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy|
- Tumor response [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||November 1997|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003135
|United States, Texas|
|University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77225|
|Study Chair:||Joan M.C. Bull, MD||The University of Texas Health Science Center, Houston|