A Phase 2 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
Lung cancer remains the most common cancer and cause of cancer-related mortality in the
United States. In 2008, there was an estimated 215,000 new cases of lung cancer diagnosed
and roughly 162,000 deaths from lung cancer (NCI 2009). The majority (85%) of patients with
a diagnosis of lung cancer will have non-small cell lung cancer (NSCLC).
The combination of paclitaxel and carboplatin has become the most commonly prescribed
chemotherapy regimen for the treatment of advanced NSCLC in the United States. Laboratory
studies of combinations of REOLYSIN with a variety of chemotherapeutic agents has shown that
the combination of REOLYSIN and paclitaxel was invariably synergistic, even in cells with
drug resistance or limited sensitivity to the reovirus. Moreover, reovirus activity was
dramatically increased in the presence of the taxane.
The Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given
intravenously in combination with paclitaxel and carboplatin every 3 weeks in patients with
squamous cell carinoma of the lung.
Response is a primary endpoint of this trial.
The safety of the treatment combination will be assessed by the evaluation of the type,
frequency and severity of adverse events, changes in clinical laboratory tests,
immunogenicity and physical examination.
Patients may continue to receive chemotherapy combined with REOLYSIN for up to 8 cycles and
may continue indefinitely on REOLYSIN monotherapy under this protocol, provided they have
not experienced either progressive disease or unacceptable drug-related toxicity that does
not respond to either supportive care or dose reduction.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population
Alain Mita, MD
Cedars-Sinai Medical Center
United States: Food and Drug Administration
|Cedars-Sinai Medical Center||Los Angeles, California 90048|
|Ocala Oncology Center||Ocala, Florida 34474|
|Advanced Oncology Associates||Armonk, New York 10504|
|Cancer Care Centers of South Texas||San Antonio, Texas 78229|
|Investigative Clinical Research of Indiana, LLC||Indianapolis, Indiana 46254|
|Signal Point Clinical Research Center, LLC||Middletown, Ohio 45042|
|Texas Oncology - Tyler||Tyler, Texas 75702|
|Texas Oncology - Arlington South||Arlington, Texas 76014-2084|
|Cancer Therapy & Research Center at UTHSCSA||San Antonio, Texas 78229|
|Illinois Cancer Specialists||Niles, Illinois 60714|
|Medical Oncology Associates of Wyoming Valley||Kingston, Pennsylvania 18704|
|Texas Oncology - Bedford||Bedford, Texas 76022|
|Texas Oncology - Denton South||Denton, Texas 76210|
|Texas Oncology - Fort Worth||Fort Worth, Texas 76104|
|Texas Oncology - Garland||Garland, Texas 75042|
|Texas Oncology - Lewisville||Lewisville, Texas 75067|
|Lynchburg Hematology Oncology Clinic||Lynchburg, Virginia 24501|