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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Oncolytics Biotech
ClinicalTrials.gov Identifier:
NCT00998192
First received: October 15, 2009
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Oncolytics Biotech:

Primary Outcome Measures:
  • Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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. [ Time Frame: Within 30 days of last dose of REOLYSIN ] [ Designated as safety issue: Yes ]
  • To assess progression-free survival (PFS) for the treatment regimen in the study population. [ Time Frame: 9-12 months ] [ Designated as safety issue: No ]
  • Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To determine overall survival with the treatment regimen in the study population [ Time Frame: 9-12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998192

Locations
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 Care Centers of South Texas
San Antonio, Texas, United States, 78258-3912
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
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
Investigators
Principal Investigator: Alain Mita, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Oncolytics Biotech
ClinicalTrials.gov Identifier: NCT00998192     History of Changes
Other Study ID Numbers: REO 021
Study First Received: October 15, 2009
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Oncolytics Biotech:
carcinoma
squamous cell
lung
REOLYSIN
chemotherapy
carboplatin
paclitaxel
Carcinoma, Squamous Cell of the Lung

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 23, 2014