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Sponsored by: |
Oncolytics Biotech |
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Information provided by: | Oncolytics Biotech |
ClinicalTrials.gov Identifier: | NCT00861627 |
The purpose of this Phase 2 study is to investigate whether intravenous administration of a wild type reovirus (REOLYSIN®) in combination with paclitaxel and carboplatin is effective and safe in the treatment of Non-Small Cell Lung Cancer with KRAS or EGFR activation.
Condition | Intervention | Phase |
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Carcinoma, Non-Small Cell Lung |
Biological: REOLYSIN® Drug: Carboplatin Drug: Paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study of Intravenous Administration of Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) in Combination With Paclitaxel and Carboplatin in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer Who Have KRAS or EGFR Activated Tumors |
Estimated Enrollment: | 36 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) is a naturally occurring, ubiquitous, non-enveloped human reovirus. Reovirus has been shown to replicate selectively in Ras-transformed cells causing cell lysis. Activating mutations in ras or mutation in oncogenes signaling through the ras pathway may occur in as many as 80% of human tumors. The specificity of the reovirus for Ras-transformed cells, coupled with its relatively nonpathogenic nature in humans, makes it an attractive anti-cancer therapy candidate.
Given the ability of reovirus to replicate and cause oncolysis in Ras-activated cells, the high incidence of K-ras mutations in lung cancers, and the Ras-mediated activation often encountered in EGFR-addicted tumors, the administration of REOLYSIN® in combination with chemotherapy is expected to result in enhanced clinical benefit in non-small cell lung cancer (NSCLC) patients with K-ras mutations and/or EGFR aberrant activation in their tumors.
Patients with de novo or acquired EGFR mutations in their tumors that confer resistance to EGFR TKIs (e.g. T790) are expected to benefit as well. This is a single arm, open-label, Phase 2 study of REOLYSIN® given intravenously with paclitaxel and carboplatin every 3 weeks (21 days is defined as a cycle) in NSCLC patients with tumors driven by these pathways.
Paclitaxel at a dose of 200 mg/m2 will be given i.v. as a 3 hour infusion on Day 1 followed by carboplatin given i.v. AUC 6 mg/mL•minute. REOLYSIN® will be given over 60 min on Day 1 (starting after completion of the carboplatin infusion), and on Days 2 - 5. The treatment cycle will be repeated every 21 days.
Patients will receive 4 to 6 cycles of paclitaxel and carboplatin, at the treating physician's discretion according to standard of practice, in conjunction with REOLYSIN®. After completion of the 4 to 6 cycles of paclitaxel and carboplatin, REOLYSIN® may be continued as monotherapy Days 1-5 of each 21 day cycle until there is evidence of disease progression or unacceptable toxicity. 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:
have baseline laboratory results as follows:
Exclusion Criteria:
United States, Ohio | |
The Ohio State University Medical Center, James Cancer Hospital and Solove Research Institute | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Miguel Villalona, MD 866-627-7616 osu@emergingmed.com | |
Principal Investigator: Miguel Villalona, MD |
Principal Investigator: | Miguel Villalona, MD | Ohio State University |
Responsible Party: | Oncolytics Biotech Inc. ( Dr. Karl Mettinger ) |
Study ID Numbers: | REO 016 |
Study First Received: | March 12, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861627 History of Changes |
Health Authority: | United States: Food and Drug Administration |
REOLYSIN reovirus non-small cell lung cancer carcinoma |
oncolytics virus chemotherapy paclitaxel carboplatin |
Thoracic Neoplasms Antimitotic Agents Carboplatin Recurrence Carcinoma Virus Diseases Respiratory Tract Diseases Lung Neoplasms |
Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |