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

Primary Purpose

Metastatic or Recurrent Squamous Cell Carcinoma of the Lung

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
REOLYSIN
Paclitaxel
Carboplatin
Sponsored by
Oncolytics Biotech
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic or Recurrent Squamous Cell Carcinoma of the Lung focused on measuring carcinoma, squamous cell, lung, REOLYSIN, chemotherapy, carboplatin, paclitaxel, Carcinoma, Squamous Cell of the Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai Medical Center
  • Ocala Oncology Center
  • Illinois Cancer Specialists
  • Investigative Clinical Research of Indiana, LLC
  • Advanced Oncology Associates
  • Signal Point Clinical Research Center, LLC
  • Medical Oncology Associates of Wyoming Valley
  • Texas Oncology - Arlington South
  • Texas Oncology - Bedford
  • Texas Oncology - Denton South
  • Texas Oncology - Fort Worth
  • Texas Oncology - Garland
  • Texas Oncology - Lewisville
  • Cancer Therapy & Research Center at UTHSCSA
  • Cancer Care Centers of South Texas
  • Texas Oncology - Tyler
  • Lynchburg Hematology Oncology Clinic

Outcomes

Primary Outcome Measures

Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population

Secondary Outcome Measures

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.
To assess progression-free survival (PFS) for the treatment regimen in the study population.
Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months.
To determine overall survival with the treatment regimen in the study population

Full Information

First Posted
October 15, 2009
Last Updated
March 29, 2016
Sponsor
Oncolytics Biotech
Collaborators
University of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT00998192
Brief Title
A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oncolytics Biotech
Collaborators
University of Texas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic or Recurrent Squamous Cell Carcinoma of the Lung
Keywords
carcinoma, squamous cell, lung, REOLYSIN, chemotherapy, carboplatin, paclitaxel, Carcinoma, Squamous Cell of the Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
REOLYSIN
Intervention Description
3x10E10 TCID50 1 hour intravenous infusion, administered on Days 1,2,3,4,and 5 of a 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
6 AUC mg/mL min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle
Primary Outcome Measure Information:
Title
Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Title
To assess progression-free survival (PFS) for the treatment regimen in the study population.
Time Frame
9-12 months
Title
Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months.
Time Frame
6 months
Title
To determine overall survival with the treatment regimen in the study population
Time Frame
9-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Mita, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Investigative Clinical Research of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Advanced Oncology Associates
City
Armonk
State/Province
New York
ZIP/Postal Code
10504
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Medical Oncology Associates of Wyoming Valley
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Texas Oncology - Arlington South
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology - Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Texas Oncology - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology - Garland
City
Garland
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
Facility Name
Texas Oncology - Lewisville
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75067
Country
United States
Facility Name
Cancer Therapy & Research Center at UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258-3912
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Lynchburg Hematology Oncology Clinic
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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