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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2013
• Main ID: NCT00998192
• Date of registration: 15/10/2009
• Primary sponsor: Oncolytics Biotech
• Public title: A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
• Scientific 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
• Date of first enrolment: October 2009
• Target sample size: 55
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00998192
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Alain Mita, MD
• Affiliation: Cedars-Sinai Medical Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Metastatic or Recurrent Squamous Cell Carcinoma of the Lung

Intervention(s)

Biological: REOLYSIN

Drug: Carboplatin

Drug: Paclitaxel

Primary Outcome(s)

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

Secondary Outcome(s)

Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months. [Time Frame: 6 months]

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]

To assess progression-free survival (PFS) for the treatment regimen in the study population. [Time Frame: 9-12 months]

To determine overall survival with the treatment regimen in the study population [Time Frame: 9-12 months]

Secondary ID(s)

REO 021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Texas