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Carcinoma, Squamous Cell of the Head and NeckPhase 2NCT00753038

Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck Carcinoma

A Phase 2 study testing REOLYSIN®, Carboplatin and Paclitaxel in people with Carcinoma, Squamous Cell of the Head and Neck, run by Oncolytics Biotech at 2 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 carcinoma of the head and neck. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
REOLYSIN®, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
How many people
14 participants
Where
2 sitesUnited States
Study dates
Aug 2008to May 2013
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 platinum-refractory metastatic and/or recurrent histologically confirmed stage III/IV squamous cell carcinoma of the head and neck (oral cavity, larynx or pharynx) with no secondary cancers
  • have evidence of measurable disease
  • have documented progressive disease (PD) on or within 190 days following the completion of treatment of cisplatin-based or carboplatin-based chemotherapy in a recurrent or metastatic setting and if treatment with cetuximab was considered indicated for the patient, documented PD(on or within 190 days of treatment)
  • have no continuing acute toxic effect of any prior radiotherapy, chemotherapy or surgical procedures
  • have received no chemotherapy, radiotherapy, immunotherapy or hormonotherapy within 28 days
  • have ECOG performance score of ≤2
Show all 9Show fewer
  • have life expectancy of at least 3 months
  • absolute neutrophils ≥ 1.5 x10^9/L; platelets ≥100 x10^9; hemoglobin ≥9.0 g/dL; serum creatinine ≤1.5 xULN; bilirubin ≤1.5 x ULN; AST/ALT ≤2.5xULN
  • negative pregnancy test for females of childbearing potential

Who cannot join

  • have known brain metastasis
  • have known bone metastasis
  • be on immunosuppressive therapy; 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 severe, 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 judgement of the Principal Investigator, would make the patient inappropriate for this study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cancer Therapy and Research Center at UTHSCSA

    San Antonio, Texas, 78229

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Phase 2 Study of Intravenous Administration of a Wild-Type Reovirus (REOLYSIN®) in Combination With Paclitaxel and Carboplatin in Patients With Platinum-Refractory Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck.

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 carcinoma of the head and neck.

Read the detailed description

Squamous cell carcinoma of the head and neck is the sixth most common cancer in the world. More than 50% of patients diagnosed with advanced regional disease will relapse locally or at distant sites. Initial therapeutic options include irradiation, surgery and chemotherapy. The most commonly used agents are cisplatin and carboplatin, generally in combination with 5-FU or a taxane. Erbitux has recently been approved for use in first-line with radiation and in second-line as monotherapy. Only about a third of the patients will respond to first-line platinum-based therapy and the median overall survival is 6-9 months.

Preliminary assessment of a Phase 1 study being conducted in the UK investigating the combination of REOLYSIN®, carboplatin and paclitaxel suggested that patients with head and neck carcinomas may represent a group of patients in whom this treatment combination is active.

This 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 carcinoma of the head and neck.

Response is a primary endpoint of this trial. Patients will be clinically evaluated after each course of treatment and radiologically every other cycle. A complete or partial response must be confirmed at least 4 weeks after the first assessment that documents such a response and every two cycles thereafter.

The safety of the paclitaxel, carboplatin and REOLYSIN® 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 therapy 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®, Carboplatin, Paclitaxel
Keywords
carcinoma, squamous cell, head, neck, REOLYSIN, chemotherapy, Carboplatin, Paclitaxel
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma

What participants receive

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

  • REOLYSIN®Biological

    3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle

  • CarboplatinDrug

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

  • PaclitaxelDrug

    175 mg/m2, 3 hour 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. Determine the objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population

    Measured: For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met.

Secondary outcomes (2)

  1. Evaluate the safety and tolerability of the treatment regimen in the study population.

    Measured: Within 30 days of last dose of REOLYSIN®

  2. Determine the disease control rate (CR, PR and stable disease (SD)), duration of response, time to disease progression and survival with the treatment regimen in the study population.

    Measured: For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met. For SD, follow-up measurements must have met the SD criteria at least once after trial entry at a minimum interval of 12 weeks.

Timeline

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

  1. First posted16 Sep 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJul 2011
  4. Study completionMay 2013

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00753038
Sponsor's protocol ID
REO 015
Status last verified
Nov 2014
First submitted
12 Sep 2008
Last updated
4 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing REOLYSIN®, Carboplatin and Paclitaxel in people with Carcinoma, Squamous Cell of the Head and Neck, run by Oncolytics Biotech at 2 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 9 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Determine the objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population (time frame: For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met.). 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 NCT00753038.

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 4 Nov 2014.

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