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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

Phase 2
18 Years
Open (Enrolling)
Metastatic or Recurrent Squamous Cell Carcinoma of the Lung

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Trial Information

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

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.

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

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Alain Mita, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center


United States: Food and Drug Administration

Study ID:

REO 021



Start Date:

October 2009

Completion Date:

September 2013

Related Keywords:

  • Metastatic or Recurrent Squamous Cell Carcinoma of the Lung
  • carcinoma
  • squamous cell
  • lung
  • chemotherapy
  • carboplatin
  • paclitaxel
  • Carcinoma, Squamous Cell of the Lung
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Lung Neoplasms



Cedars-Sinai Medical CenterLos Angeles, California  90048
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