Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
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| ClinicalTrials.gov Identifier: NCT00003135 |
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Recruitment Status : Unknown
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : January 27, 2003
Last Update Posted : April 30, 2009
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Cervical Cancer Endometrial Cancer Ovarian Cancer | Drug: fluorouracil Drug: pegylated liposomal doxorubicin hydrochloride Procedure: hyperthermia treatment | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 34 participants |
| 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 |
| Study Start Date : | November 1997 |
| Estimated Primary Completion Date : | September 2009 |
- Tumor response
- Toxicity
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes 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%
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003135
| 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 |
| Responsible Party: | Joan M.C. Bull, University of Texas Health Science Center at Houston |
| ClinicalTrials.gov Identifier: | NCT00003135 |
| Other Study ID Numbers: |
CDR0000065903 UTHSC-MS-96205 NCI-V97-1356 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | April 30, 2009 |
| Last Verified: | December 2008 |
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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 |
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Breast Neoplasms Uterine Cervical Neoplasms Endometrial Neoplasms Fever Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Genital Neoplasms, Female Urogenital Neoplasms Uterine Neoplasms Uterine Cervical Diseases Uterine Diseases Body Temperature Changes |
Doxorubicin Liposomal doxorubicin Fluorouracil Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |