A Phase 2 Study Comparing Sequential Satraplatin and Erlotinib to Single-Agent Erlotinib in Patients = 70 Years of Age With Unresectable Stage 3 OR 4 Non-Small Cell Lung Cancer as 1st-Line Therapy
Patients = 70 years of age with locally advanced unresectable or metastatic non-small cell
lung cancer (NSCLC) frequently do not receive systemic cytotoxic chemotherapy due to
concerns regarding their inability to tolerate treatment. Epidermal growth factor receptor
(EGFR) tyrosine kinase inhibitors (TKIs) are agents with favorable toxicity profiles that
have shown activity in patients with NSCLC. Erlotinib as a single-agent is currently
approved for the treatment of patients with NSCLC whose disease has progressed following one
prior course of chemotherapy and is currently being evaluated in NSCLC patients who have not
received prior systemic treatment. However, when studied with combination chemotherapy in
the first-line setting, continuous daily administration of erlotinib did not result in
improved patient survival. Further clinical and in vitro data suggest that the sequencing
of cytotoxic chemotherapy with EGFR TKIs is important to maximize their therapeutic
potential when administered in combination.
Satraplatin is an oral, investigational anticancer drug that is a member of the
platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven
to be one of the most effective classes of anticancer therapies. Unlike the currently
marketed platinum-based drugs, satraplatin can be given orally and is currently being
evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone
refractory prostate cancer.
The rationale for this study is to develop an active and well-tolerated oral regimen for
patients = 70 years of age with NSCLC. Administration of the study drugs will be sequenced
with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle.
The primary endpoint will be progression-free survival (PFS). Patients will be randomized to
treatment with either the experimental regimen or single-agent continuous erlotinib.
Study Status: Completed
Information provided by:
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
Corey Langer, MD., Principal Investigator