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Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.

Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart

Dichloroacetate (DCA)

Edward Garon, MD

The purpose of this study is 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.

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.

Dichloroacetate (DCA) in Patients With Previously Treated Metastatic Breast or Non-Small Cell Lung Cancer (NSCL)

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

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Jonsson Comprehensive Cancer Center

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Stage II breast cancer

Stage IV NSCLC

stage at diagnosis

ECOG status 0

ECOG status 1

ECOG status 2

ECOG status

Stage 1 has best prognosis and stage IV has worst.Grade 1 is associated with best prognosis and grade 3 with poor prognosis.ECOG performance status grades a person's overall well-being and scaled from 0-5.ECOG of 0 is associated with best prognosis.Patients with ECOG 0-2 are considered well enough to receive additional treatments for their cancer.

The greatest limitation in our study was early termination due to perceived lack of drug efficacy leading to small number of subjects analyzed.

Intent to treat analysis was performed. Zero patients achieved complete or partial response in this study.

Response Rate by RECIST Criteria of Oral Dichloroacetate in Patients With Recurrent and/or Metastatic and Pretreated Breast and Non-small Cell Lung Cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dichloroacetate (DCA) in Patients With Previously Treated Metastatic Breast or Non-Small Cell Lung Cancer (NSCL)	NCT01029925	Metastatic Brea... Lung Cancer	Dichloroacetate...	18 Years -	Jonsson Comprehensive Cancer Center
Dichloroacetate (DCA) in Patients With Previously Treated Metastatic Breast or Non-Small Cell Lung Cancer (NSCL)	NCT01029925	Metastatic Brea... Lung Cancer	Dichloroacetate...	18 Years -	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for previously treated metastatic breast cancer