|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | The University of Texas Health Science Center, Houston |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003135 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Cervical Cancer Endometrial Cancer Ovarian Cancer |
Drug: fluorouracil Drug: pegylated liposomal doxorubicin hydrochloride Procedure: hyperthermia treatment |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy |
| Estimated Enrollment: | 34 |
| Study Start Date: | November 1997 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Texas | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77225 | |
| Contact: Joan M.C. Bull, MD 713-500-6820 joan.m.bull@uth.tmc.edu | |
| Study Chair: | Joan M.C. Bull, MD | The University of Texas Health Science Center, Houston |
More Information
| Responsible Party: | University of Texas Health Science Center at Houston ( Joan M.C. Bull ) |
| Study ID Numbers: | CDR0000065903, UTHSC-MS-96205, NCI-V97-1356 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003135 History of Changes |
| Health Authority: | Unspecified |
|
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 |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic Genital Diseases, Female Endometrial Neoplasms Neoplasms by Site Therapeutic Uses Uterine Neoplasms |
Breast Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Skin Diseases Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Uterine Diseases Immunosuppressive Agents Doxorubicin Pharmacologic Actions Adnexal Diseases Neoplasms Fluorouracil |