Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recurrent Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

  • Locally recurrent disease involving the chest wall and/or its overlying skin

    • Clinically and biopsy proven disease on the chest wall area measuring ≥ 1 cm
    • Overall surface extent of tumor ≤ two 16 x 16 cm fields
    • Tumor thickness ≤ 3 cm by clinical exam and CT scan or MRI
    • Disease extent on the chest wall that exceeds the above criteria allowed provided no other local therapies are available
    • Patients with axillary disease involvement only must meet the above criteria in order to be eligible
    • Prior skin changes consistent with inflammatory breast cancer are allowed

• Distant metastasis (excluding known brain metastases) allowed

  • No resectable chest wall recurrence as the only site of metastatic disease
  • No refractory pain secondary to metastatic disease
• Must have undergone prior local radiotherapy to the chest wall or breast in the adjuvant or metastatic setting
• Must have progressed on ≥ 1 course of hormonal therapy for metastatic disease (if tumor is estrogen receptor positive or progesterone receptor positive) AND ≥ 1 course of chemotherapy
• Prior contralateral breast malignancy allowed provided not previously treated with chemotherapy
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Female
• Menopausal status not specified
• Zubrod performance status 0-1 OR Karnofsky performance status 90-100%
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL
• Bilirubin normal
• alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• left ventricular ejection fraction (LVEF) ≥ 50% by multiple gated acquisition scan (MUGA) or echocardiogram
• No nonhealing wounds or active infection in the area of the chest wall
• No clinically significant findings on baseline evaluations, including laboratory and physical examinations, vital signs, and ECG
• No prior sensitivity (e.g., rash, dyspnea, wheezing, urticaria, or other symptoms) attributed to anthracyclines or other liposomally encapsulated drugs
• No other prior or concurrent primary malignancy except for melanoma in situ, nonmelanoma skin cancer, squamous cell carcinoma, or noninvasive cervical carcinoma

• No history of any of the following:

  • Cardiac ischemia or acute coronary artery syndrome, myocardial infarction (MI), cerebral vascular accident, or abnormal cardiac stress testing within the last 6 months
  • Coronary artery disease (including non-Q wave MI)
  • Uncontrolled hypertension or cardiomyopathy
  • Cardiac valvular surgery or open heart surgery
  • Known structural heart disease

• No other serious medical illness including, but not limited to, the following:

  • Congestive heart failure
  • Life-threatening cardiac arrhythmias
  • Acute or chronic liver disease
• No major psychiatric illness that required inpatient treatment within the past 3 months or that would preclude obtaining informed consent

• No concurrent devices or conditions that might interfere with the hyperthermia portion of the trial, including any of the following:

  • Functioning cardiac pacemaker
  • Metal plates, rods, or prosthesis of the chest wall
  • Severe numbness and/or tingling of the chest wall or breast
  • Skin grafts and/or flaps on the breast or chest wall
  • Unstable cardiovascular or pulmonary status
• No known allergy to eggs or egg products

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 3 months since prior major surgery

• No prior therapy with anthracyclines exceeding the following doses:

  • Doxorubicin hydrochloride > 450 mg/m^2
  • Epirubicin hydrochloride > 900 mg/m^2
• More than 42 days since prior trastuzumab (Herceptin®)
• More than 90 days since prior radiotherapy to the involved chest wall area
• No other concurrent systemic anticancer therapy, including hormonal therapy, chemotherapy, or investigational anticancer therapy
• No concurrent radiotherapy, including radiotherapy for pain control

• No concurrent administration of any of the following drugs:

  • Amphotericin B by injection
  • Antithyroid agents
  • Azathioprine
  • Chloramphenicol
  • Colchicine
  • Flucytosine
  • Ganciclovir
  • Interferon
  • Plicamycin
  • Zidovudine
  • Sulfinpyrazone
  • Probenecid
  • Cyclosporine
  • Phenobarbital
  • Phenytoin
  • Streptozocin
  • Live vaccines
• Concurrent bisphosphonates for palliation of bony metastasis allowed