Last updated on April 2009

Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast Ovarian Endometrial or Cervical Cancer


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ovarian Cancer | Endometrial Cancer | Breast Cancer | Cervical Cancer
  • Age: Between 18 - 100 Years
  • Gender: Female
  • Other:
    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
    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
    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
    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
    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
    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
    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
    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

Recruitment Status: Open


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