A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Allocation: Non-Randomized 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 |
- 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 ]
- 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: | September 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
-
Biological: REOLYSIN
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 |
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| 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 | |
| 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: | May 7, 2013 |
| 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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases |
Respiratory Tract Diseases Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013