A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung

Completed · Phase 2

Conditions studied: Metastatic or Recurrent Squamous Cell Carcinoma of the Lung

In brief

The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic reovirus in combination with paclitaxel and carboplatin is effective and safe in the treatment of squamous cell carinoma of the lung.

Key facts

Study ID

NCT00998192

Run by

Oncolytics Biotech

People needed

32

Starts

2009-10-01

Expected to finish

2015-08-01

Last updated by the study team

2016-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• have histologically or cytologically confirmed metastatic stage IIIB (pleural effusion; IVA on revised IASLC staging) or stage IV, or recurrent squamous cell carcinoma of the lung.
• have measurable disease.
• be chemotherapy naïve for their metastatic or recurrent SCCLC, with some exceptions.
• have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures.
• have an ECOG Performance Score of ≤ 2.
• have a life expectancy of at least 3 months.
• absolute neutrophil count (ANC) ≥ 1.5 x 10\^9; Platelets ≥ 100 x10\^9 (without platelet transfusion);Hemoglobin ≥ 9.0 g/dL (with or without RBC transfusion); Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN.
• negative pregnancy test for females with childbearing potential.

You may not qualify if…

• receive concurrent therapy with any other investigational anticancer agent while on study.
• have a known past or current history of brain metastasis(es).
• be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
• be a pregnant or breast-feeding woman.
• have clinically significant cardiac disease.
• have dementia or altered mental status that would prohibit informed consent.
• have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Illinois Cancer Specialists — Niles, Illinois, United States
• Investigative Clinical Research of Indiana, LLC — Indianapolis, Indiana, United States
• Advanced Oncology Associates — Armonk, New York, United States
• Signal Point Clinical Research Center, LLC — Middletown, Ohio, United States
• Medical Oncology Associates of Wyoming Valley — Kingston, Pennsylvania, United States
• Texas Oncology - Arlington South — Arlington, Texas, United States
• Texas Oncology - Bedford — Bedford, Texas, United States
• Texas Oncology - Denton South — Denton, Texas, United States
• Texas Oncology - Fort Worth — Fort Worth, Texas, United States
• Texas Oncology - Garland — Garland, Texas, United States
• Texas Oncology - Lewisville — Lewisville, Texas, United States
• Cancer Therapy & Research Center at UTHSCSA — San Antonio, Texas, United States
• Cancer Care Centers of South Texas — San Antonio, Texas, United States
• Texas Oncology - Tyler — Tyler, Texas, United States
• Lynchburg Hematology Oncology Clinic — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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