Pilot and Phase II- Vorinostat and Lapatinib in Patients With Advanced Solid Tumor Malignancies and Women With Recurrent Local-Regional or Metastatic Breast Cancer to Evaluate Response and Biomarkers of EMT and Breast Cancer Stem Cells
Lapatinib is an anti-cancer drug that is approved by the Food and Drug Administration (FDA)
for the treatment of metastatic HER2-positive breast cancer. HER2 is a protein involved in
the growth of some cancer cells. In lab tests and small clinical studies, lapatinib is also
found to kill other types of cancer that have another related protein called epidermal
growth factor receptor (EGFR). For participants who have other cancers, the use of lapatinib
in this study is investigational. This means the drug is not FDA approved for this use.
Vorinostat is only FDA approved for the treatment of cutaneous T cell lymphoma (a type of
cancer). Vorinostat is not currently FDA approved for breast cancer or any other type of
cancer. The use of vorinostat in this study is investigational.
Cancer cells can travel through the blood stream and spread to other organs. This process is
called metastasis. Lab tests and small clinical trials have shown that vorinostat kills some
cancer cells and prevents these cancer cells from traveling through the blood stream. These
trials have shown that vorinostat improves how well lapatinib kills cancer cells.
Newer studies have also shown that a subset of cells, called "cancer stem cells," can come
back, spread, and become resistant to the usual chemotherapy. In laboratory tests, we found
that vorinostat and lapatinib can reduce the number of cancer stem cells. We are looking at
combining vorinostat and lapatinib in the hope that we can reduce the number of cancer stem
cells and cancer cells traveling through the blood stream.
There are two parts to this study.
First part- We want to learn more about the best dose of vorinostat to be given with
lapatinib. We want to learn about how much vorinostat and lapatinib goes into the blood
during treatment. We also want to learn the side effects (safety) of the combination of
vorinostat and lapatinib. All patients will receive the FDA-approved dose of lapatinib. The
first group of patients will get a slightly lower dose of vorinostat than is given normally.
If the side effects are not too serious, the next group of patients will get the dose of
vorinostat that is given normally.
Second part- We will find out how well the combination of vorinostat and lapatinib works in
patients with HER2-positive metastatic breast cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical benefit rate (Complete Response (CR), Partial Response (PR), and Stable Disease (SD) ≥ 6 months) of vorinostat in combination with lapatinib in patients with locally recurrent or metastatic breast cancer.
Radiological evaluations are performed every 12 weeks to determine disease status
Saranya Chumsri, MD
University of Maryland
United States: Institutional Review Board
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|