Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recurrent Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage III B breast cancer, stage III C breast cancer, stage IV breast cancer, inflammatory breast cancer, recurrent breast cancer
Eligibility Criteria
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
Sites / Locations
- Duke Cancer Institute
Arms of the Study
Arm 1
Experimental
Thermodox
ThermoDox20-40mg/m2 every 21-35 days followed by Chest Wall Hyperthermia