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Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer Clinical research trials and Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "W" Clinical Trials Conditions > Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer  Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
For Condition: Breast Cancer,ovarian epithelial cancer,Endometrial Cancer,Cervical Cancer,Male Breast Cancer,ovarian germ cell tumor
Status: Recruiting
Sponsor(s): University of Texas ,
Synopsis: 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: Phase II trial to study the effectiveness of fluorouracil and liposomaldoxorubicin combined with systemic hyperthermia in treating patients with metastatic breast, ovarian, endometrial, or cervical cancer.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoanBull, Study Chair, University of Texas
University of Texas Health Science Center - Houston *Recruiting*
Houston, Texas, 77225
United States
Recruiting Joan Bull 713-500-6820
Additional Information:
Study ID Numbers: CDR0000065903; UTHSC-MS-96205,NCI-V97-1356
Study Start Date:
Record last reviewed: March 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003135
Other Cervical Cancer Studies:
1. Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer
2. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
3. BMS-247550 in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
4. Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients
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Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
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