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Metastatic or Recurrent Squamous Cell Carcinoma of the LungPhase 2NCT00998192

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

A Phase 2 study testing REOLYSIN, Paclitaxel and Carboplatin in people with Metastatic or Recurrent Squamous Cell Carcinoma of the Lung, run by Oncolytics Biotech at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
REOLYSIN, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
How many people
32 participants
Where
17 sitesUnited States
Study dates
Oct 2009to Aug 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Texas Oncology - Arlington South

    Arlington, Texas, 76014

  • Advanced Oncology Associates

    Armonk, New York, 10504

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • Texas Oncology - Denton South

    Denton, Texas, 76210

  • Texas Oncology - Fort Worth

    Fort Worth, Texas, 76104

  • Texas Oncology - Garland

    Garland, Texas, 75042

  • Investigative Clinical Research of Indiana, LLC

    Indianapolis, Indiana, 46260

  • Medical Oncology Associates of Wyoming Valley

    Kingston, Pennsylvania, 18704

  • Texas Oncology - Lewisville

    Lewisville, Texas, 75067

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Lynchburg Hematology Oncology Clinic

    Lynchburg, Virginia, 24501

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio, 45042

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Ocala Oncology Center

    Ocala, Florida, 34471

  • Cancer Therapy & Research Center at UTHSCSA

    San Antonio, Texas, 78229

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78258-3912

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
REOLYSIN, Paclitaxel, Carboplatin
Keywords
carcinoma, squamous cell, lung, REOLYSIN, chemotherapy, carboplatin, paclitaxel, Carcinoma, Squamous Cell of the Lung
Medical subject headings
Neoplasm Metastasis, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REOLYSINBiological

    3x10E10 TCID50 1 hour intravenous infusion, administered on Days 1,2,3,4,and 5 of a 21-day cycle

  • PaclitaxelDrug

    Also called Taxol

    200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle

  • CarboplatinDrug

    Also called Paraplatin

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (4)

  1. 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.

    Measured: Within 30 days of last dose of REOLYSIN

  2. To assess progression-free survival (PFS) for the treatment regimen in the study population.

    Measured: 9-12 months

  3. Determine the proportion of patients receiving the treatment who are alive and free of disease progression at 6 months.

    Measured: 6 months

  4. To determine overall survival with the treatment regimen in the study population

    Measured: 9-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionSep 2013
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00998192
Sponsor's protocol ID
REO 021
Status last verified
Aug 2015
First submitted
15 Oct 2009
Last updated
31 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REOLYSIN, Paclitaxel and Carboplatin in people with Metastatic or Recurrent Squamous Cell Carcinoma of the Lung, run by Oncolytics Biotech at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00998192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.

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