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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00998192
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : March 31, 2016
University of Texas
Information provided by (Responsible Party):
Oncolytics Biotech

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic or Recurrent Squamous Cell Carcinoma of the Lung Biological: REOLYSIN Drug: Paclitaxel Drug: Carboplatin Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Intervention Details:
  • Biological: REOLYSIN
    3x10E10 TCID50 1 hour intravenous infusion, administered on Days 1,2,3,4,and 5 of a 21-day cycle
  • Drug: Paclitaxel
    200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle
    Other Name: Taxol
  • Drug: Carboplatin
    6 AUC mg/mL min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle
    Other Name: Paraplatin

Primary Outcome Measures :
  1. Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Evaluate the safety and tolerability of the treatment regimen in the study population as measured by adverse events associated with the study treatment, and defined by established criteria. [ Time Frame: Within 30 days of last dose of REOLYSIN ]
  2. To assess progression-free survival (PFS) for the treatment regimen in the study population. [ Time Frame: 9-12 months ]
  3. Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months. [ Time Frame: 6 months ]
  4. To determine overall survival with the treatment regimen in the study population [ Time Frame: 9-12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00998192

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Ocala Oncology Center
Ocala, Florida, United States, 34471
United States, Illinois
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
United States, Indiana
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, United States, 46260
United States, New York
Advanced Oncology Associates
Armonk, New York, United States, 10504
United States, Ohio
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States, 45042
United States, Pennsylvania
Medical Oncology Associates of Wyoming Valley
Kingston, Pennsylvania, United States, 18704
United States, Texas
Texas Oncology - Arlington South
Arlington, Texas, United States, 76014
Texas Oncology - Bedford
Bedford, Texas, United States, 76022
Texas Oncology - Denton South
Denton, Texas, United States, 76210
Texas Oncology - Fort Worth
Fort Worth, Texas, United States, 76104
Texas Oncology - Garland
Garland, Texas, United States, 75042
Texas Oncology - Lewisville
Lewisville, Texas, United States, 75067
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78258-3912
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
United States, Virginia
Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Oncolytics Biotech
University of Texas
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Principal Investigator: Alain Mita, MD Cedars-Sinai Medical Center

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Responsible Party: Oncolytics Biotech Identifier: NCT00998192     History of Changes
Other Study ID Numbers: REO 021
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: August 2015
Keywords provided by Oncolytics Biotech:
squamous cell
Carcinoma, Squamous Cell of the Lung
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action