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

Metastatic or Recurrent Squamous Cell Carcinoma of the Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998192
• Other study ID #: REO 021
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2009
• Last updated: August 28, 2015
• Start date: October 2009
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Oncolytics Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Lung Neoplasms
• Metastatic or Recurrent Squamous Cell Carcinoma of the Lung

Intervention

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
• Carboplatin
6 AUC mg/mL min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Oncolytics Biotech	University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population		6 months	No
Secondary	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.		Within 30 days of last dose of REOLYSIN	Yes
Secondary	To assess progression-free survival (PFS) for the treatment regimen in the study population.		9-12 months	No
Secondary	Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months.		6 months	No
Secondary	To determine overall survival with the treatment regimen in the study population		9-12 months	No