Phase I Trial of Carboplatin and Etoposide in Combination With Everolimus (RAD001) in Advanced Solid Tumors, With Emphasis on Small Cell Lung Cancer (SCLC)
OBJECTIVES:
Primary
- Determine the safety and feasibility of everolimus combined with carboplatin and
etoposide in patients with advanced solid tumors, with emphasis on small cell lung
cancer (SCLC).
Secondary
- Determine the maximum-tolerated dose of this regimen in these patients.
- Describe the dose-limiting toxicities and toxicity profile associated with this regimen
in these patients.
- Determine, preliminarily, the efficacy of this regimen in an expanded cohort of
patients with SCLC.
- Assess the pharmacokinetic parameters of everolimus in this combination.
OUTLINE: This is a dose-escalation study.
Patients receive oral everolimus on days 1-21, carboplatin IV over 15-30 minutes on day 1,
and etoposide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6
courses in the absence of disease progression or unacceptable toxicity.
Patients in the expanded cohort undergo blood collection on days 1, 15, and 22 for
pharmacokinetic studies by liquid chromatography-tandem mass spectrometry.
After completion of study therapy, patients are followed for 30 days.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and feasibility
April 2011
Yes
David Gandara, MD
Principal Investigator
University of California School of Medicine - Davis
United States: Food and Drug Administration
CDR0000628772
NCT00807755
January 2009
Name | Location |
---|---|
University of California Davis Cancer Center | Sacramento, California 95817 |