Lung Cancer Clinical Trial
Official title:
Phase I Trial of Carboplatin and Etoposide in Combination With Everolimus (RAD001) in Advanced Solid Tumors, With Emphasis on Small Cell Lung Cancer (SCLC)
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,
such as carboplatin and etoposide, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. Giving more than one drug
(combination chemotherapy) together with everolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus,
carboplatin, and etoposide in treating patients with small cell lung cancer or other advanced
solid tumors.
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.
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