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
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 orally administered platinum analogue that has shown promising
single-agent activity in multiple tumor types including prostate, ovarian, and small cell
lung cancer. Additionally, the single-agent activity of satraplatin in NSCLC is similar to
that of other commonly used platinum agents used to treat NSCLC. However, satraplatin is
better tolerated than cisplatin, causing less renal toxicity and ototoxicity, and it can be
administered in the outpatient setting. From a toxicity profile, it is more similar to
carboplatin in that myelosuppression is its dose limiting toxicity (DLT). Satraplatin 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 who may not be candidates for aggressive combination
systemic chemotherapy. 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. As erlotinib has
shown an advantage in survival without a commensurate improvement in response rate, the
primary endpoint will be progression-free survival (PFS); thus patients will be randomized
to treatment with either the experimental regimen or single-agent continuous erlotinib.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare Progression-Free Survival (PFS) in patients ≥ 70 years of age, PS 0-1, with advanced or metastatic NSCLC in patients treated with a first-line regimen of either sequential satraplatin and erlotinib or continuous single-agent erlotinib.
January, 2008
Yes
Corey Langer, MD
Principal Investigator
Fox Chase Cancer Center
United States: Food and Drug Administration
SAT2-05-07
NCT00370383
July 2006
March 2009
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Scripps Clinic | La Jolla, California 92037 |
University of Miami Sylvester Cancer Center | Miami, Florida 33136 |
Kenmar Research Institute | Los Angeles, California 90057 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Pacific Cancer Medical Center | Anaheim, California 92801 |
Signal Point Hematology/Oncology | Middletown, Ohio 45042 |
Memorial Cancer Institute | Pembroke Pines, Florida 33028 |
Highlands Oncology Group | Bentonville, Ohio 72712 |