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

Primary Purpose

Carcinoma, Squamous Cell of the Head and Neck

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

REOLYSIN®

Carboplatin

Paclitaxel

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell of the Head and Neck focused on measuring carcinoma, squamous cell, head, neck, REOLYSIN, chemotherapy, Carboplatin, Paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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

Sites / Locations

Montefiore Medical Center
Cancer Therapy and Research Center at UTHSCSA

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT00753038

First Posted

September 12, 2008

Last Updated

November 3, 2014

Sponsor

Oncolytics Biotech

1. Study Identification

Unique Protocol Identification Number

NCT00753038

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oncolytics Biotech

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Squamous Cell of the Head and Neck

Keywords

carcinoma, squamous cell, head, neck, REOLYSIN, chemotherapy, Carboplatin, Paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

REOLYSIN®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

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

Time Frame

Within 30 days of last dose of REOLYSIN®

Title

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.

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monica Mita, MD

Organizational Affiliation

Cancer Therapy and Research Center, Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Cancer Therapy and Research Center at UTHSCSA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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