A Multicenter, Phase II Open-Labeled, Single-Arm Clinical and Pharmacology Study of Dichloroacetate (DCA) in Patients With Previously Treated Metastatic Breast or Non-Small Cell Lung Cancer
In the United States, approximately 180,000 new cases of breast cancer occur annually, and
there are more than 40,000 deaths. More than 150,000 cases develop each year in Canada and
the European community together, resulting in over 60,000 deaths from breast cancer. The
vast majority of patients who die from breast cancer succumb to metastatic disease.
Endocrine therapy and chemotherapy (using either sequential single agents or combination
regimens) remain the principal treatments for women with metastatic breast cancer. A wide
variety of classes of chemotherapeutic agents have activity as single agents. Median
survival remains approximately two years for women with metastatic breast cancer, and less
than 3% of patients will experience long-term survival after treatment. The development of
new treatment strategies is therefore essential to improve outcome for patients with
metastatic breast cancer. The population selected for this study will have previously
received, where appropriate, those drugs with clearly defined survival advantages
(anthracyclines, taxanes, trastuzumab, and hormonal therapy).
Patients with metastatic non-small cell lung cancer are considered incurable. Palliative
chemotherapies, such as platinum-based doublet, Taxotere or Pemetrexed or Erlotinib (an
epidermal growth factor tyrosine kinase) have been proven to improve symptoms, and survival
in patients with good performance status. Despite these treatments, the median survival of
metastatic non-small cell lung cancer is about one year. Therefore, there is an urgent need
to develop novel therapy in these patients.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate by RECIST criteria of oral dichloroacetate in patients with recurrent and/or metastatic and pretreated breast and non-small cell lung cancer.
Edward Garon, MD
University of California, Los Angeles
United States: Food and Drug Administration
DCA Breast NSCLC
|University of California, Los Angeles||Los Angeles, California|