Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
Recruitment status was Recruiting
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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 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 34 |
| Study Start Date: | November 1997 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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
Additional Information:
No publications provided
| Responsible Party: | Joan M.C. Bull, University of Texas Health Science Center at Houston |
| ClinicalTrials.gov Identifier: | NCT00003135 History of Changes |
| Other Study ID Numbers: | CDR0000065903, UTHSC-MS-96205, NCI-V97-1356 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 29, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms Fever Ovarian Neoplasms Adenoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Diseases Genital Diseases, Female |
Uterine Cervical Diseases Body Temperature Changes Signs and Symptoms Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Doxorubicin Fluorouracil Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013