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Sponsored by: |
Oncolytics Biotech |
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Information provided by: | Oncolytics Biotech |
ClinicalTrials.gov Identifier: | NCT00753038 |
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.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Squamous Cell of the Head and Neck |
Biological: REOLYSIN® Drug: Carboplatin Drug: Paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy 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. |
Estimated Enrollment: | 14 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Cancer Therapy Research Center at UTHSCSA | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Monica Mita, MD 210-450-1797 mitam@uthscsa.edu | |
Principal Investigator: Monica Mita, MD |
Study Director: | Karl Mettinger, MD, PhD | Oncolytics Biotech |
Principal Investigator: | Monica Mita, MD | Cancer Therapy Research Center at UTHSCSA |
Responsible Party: | Oncolytics Biotech ( Karl Mettinger, MD, PhD ) |
Study ID Numbers: | REO 015 |
Study First Received: | September 12, 2008 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00753038 History of Changes |
Health Authority: | United States: Food and Drug Administration |
carcinoma squamous cell head neck |
REOLYSIN chemotherapy Carboplatin Paclitaxel |
Carcinoma, Squamous Cell of Head and Neck Carboplatin Antimitotic Agents Squamous Cell Carcinoma Recurrence Carcinoma Paclitaxel |
Epidermoid Carcinoma Tubulin Modulators Neoplasms, Squamous Cell Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Carboplatin Antimitotic Agents Pharmacologic Actions Carcinoma |
Neoplasms Paclitaxel Therapeutic Uses Tubulin Modulators Neoplasms, Squamous Cell Carcinoma, Squamous Cell Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |