A Randomized Trial of Pivanex Plus Docetaxel or Docetaxel Monotherapy in Patients With Chemotherapy Resistant Advanced Non-Small Cell Carcinoma of the Lung (NSCLC)
Rationale: Pivanex is a histone deacetylase inhibitor that induces tumor differentiation
and/or apoptosis. Pivanex has been well tolerated in clinical trials and has shown
preliminary evidence of efficacy in patients with non-small cell lung cancer. Docetaxel is
an approved drug for second-line treatment of non-small cell lung cancer. Preclinical
studies indicate that the combination of Pivanex and docetaxel is synergistic.
Purpose: This open-label randomized trial will evaluate whether combination therapy with
Pivanex and docetaxel provides clinical benefit over docetaxel alone in patients with
chemotherapy resistant non-small cell lung cancer.
- Compare the survival of patients with non-small cell lung cancer treated with
combination therapy with Pivanex and docetaxel vs. docetaxel alone
- Compare the time to disease progression, tumor responses, and safety profile of
patients with non-small cell lung cancer treated with combination therapy with Pivanex
and docetaxel vs. docetaxel alone
Outline: This is a randomized, open-label, multicenter study in patients with non-small
cell lung cancer who have previously been treated with no more than one prior platinum
containing chemotherapy regimen. Patients are stratified by ECOG performance status (0-1
vs. 2), response to prior platinum based chemotherapy (progression vs. CR/PR/SD) and prior
taxane therapy (yes vs. no). Patients are randomized to 1 of 2 treatment arms.
- Arm A: Patients receive the combination of Pivanex intravenously on Days 1-3 and
docetaxel intravenously on Day 4. Treatment repeats every 21 days until disease
progression or treatment withdrawal.
- Arm B: Patients receive docetaxel intravenously on Day 1. Treatment repeats every 21
days until disease progression or treatment withdrawal.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|Wilshire Oncology Medical Group||Glendora, California 91741|
|Hematology and Oncology Specialists, LLC||New Orleans, Louisiana 70115|
|HemOnCare||Brooklyn, New York 11212|
|Montefiore Medical Center, Department of Oncology||Bronx, New York 10467|
|Gaston Hematology & Oncology Associates||Gastonia, North Carolina 28054|