Status:
TERMINATED
Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recurrent Breast Cancer
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperther...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of temperature-sensitive liposomal doxorubicin (ThermoDox™) when used in combination with local-regional hyperthermia in women with locally recurren...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00346229
Start Date
April 1 2006
End Date
April 1 2011
Last Update
March 22 2016
Active Locations (1)
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1
Duke Cancer Institute
Durham, North Carolina, United States, 27710