Phase II Clinical Trial of Carboplatin and Abraxane in Patients With Extensive Stage Small Cell Lung Cancer
Patients are being asked to be in this study because they have extensive disease small cell
lung cancer. All eligible participants who agree to be in the study will receive both
abraxane and carboplatin. The researchers want to evaluate the activity and safety of the
combination of abraxane and carboplatin, and if this combination can help people with
extensive disease small cell lung cancer.
Carboplatin is a chemotherapy drug that has been approved by the Food and Drug
Administration (FDA) to treat ovarian cancer. It is in a class of drugs known as
platinum-containing compounds. It slows or stops the growth of cancer cells in your body.
Carboplatin is not approved by the FDA for use in the treatment of small-cell lung cancer,
either alone or combined with other anti-cancer drugs. However, carboplatin given with
paclitaxel is a standard or active treatment in patients with small cell lung cancer,
non-small cell lung cancer, breast cancer, and ovarian cancer. Abraxane is a chemotherapy
drug that was approved by the FDA to treat metastatic breast cancer after other chemotherapy
has already been tried. Abraxane is a new preparation of the active ingredient in the
chemotherapy drug, paclitaxel. In a study done in breast cancer patients, Abraxane was
compared to paclitaxel. Abraxane has been shown to be more effective than paclitaxel in
tumor response and tumor progression, in addition to having fewer side effects than
paclitaxel. Abraxane was shown to cause less damage to a person's white blood cells (the
cells that fight infection) and cause fewer allergic reactions; however, more patients
developed numbness of their hands and feet.
Carboplatin and Abraxane are intravenous (IV) medications. Patients will begin treatment
with 2 cycles (1 cycle = 21 days) of abraxane and carboplatin. Then there will be a disease
assessment at cycles 2 and 4. Patients with stable disease, partial response, or complete
response will get additional cycles. Patients with progressive disease no will be taken off
the study treatment. A maximum of 6 cycles will be given.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Radiological imaging should be performed every 12 weeks, to ascertain the overall (or objective) response rate (Complete Response or Partial Response) according to the RECIST guidelines
Thomas Stinchcombe, MD
University of North Carolina, Chapel Hill
United States: Institutional Review Board
|University of North Carolina Lineberger Comprehensive Cancer Center||Chapel Hill, North Carolina 27599|