Clinical Trial: Study to Assess Biomarkers in Patients With Resectable Oral Cavity Cancer Randomized to Receive Preoperative Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Preoperative Window of Opportunity Study to Assess the Modulation of Biomarkers in the Primary Tumor Site of Patients With Resectable Oral Cavity Cancer (OCC) Randomized
Brief Summary: The objective of this study is to assess the biological effects in the primary tumor following a short, pre-operative course of treatment with PF-00298804 in patients with Oral Cavity Cancer.
Detailed Summary: This is a single-center, randomized, double-blinded, biomarker driven, preoperative window of opportunity study with a pharmacodynamic primary endpoint. Patients with resectable, histologically confirmed OCC for whom surgical treatment is planned as definitive management, will be randomized 2:1 to receive PF-00299804 pre-operatively at a dose of 45 mg once daily orally for 7-11 days or to Matching Placebo for 7-11 days depending on surgery schedule. The target is a total of 8 days of treatment but with a minimum of 7 and a maximum of 11 dosing days. All patients will receive surgery as per standard of care without delay. Biomarkers from the surgical specimen and baseline tumor biopsy or consent to provide a tumor block from existing primary diagnostic tumor biopsy completed within 90 days will be evaluated for primary and secondary pharmacodynamic endpoints.
Sponsor: University Health Network, Toronto
Current Primary Outcome: To assess the degree of modulation of the proliferation index, ki-67, in the primary tumor of OCC specimens following a short, preoperative course of PF-00299804 [ Time Frame: 8-11 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To evaluate changes in tissue and blood-based biomarkers before, during and after treatment with PF-00299804 and attempt to correlate with gene expression changes, EGFR variant III mutation status, EGFR amplification and histopathological changes [ Time Frame: 8-11 months ]
- To assess the relationship between pharmacokinetic parameters and molecular changes detected in OCC tumor specimens [ Time Frame: 8-11 months ]
- To assess the safety and tolerability of pre-operative PF-00299804 [ Time Frame: 8-11 months ]
- To quantitatively assess the effect of PF-00299804 on tumorigenic cells expressing CD44+/Lin- markers in paired OCC tumor specimens [ Time Frame: 8-11 months ]
- To evaluate gene expression changes in tumor tissue before and after treatment with PF00299804 [ Time Frame: 8-11 months ]
Original Secondary Outcome:
- To evaluate changes in tissue and blood-based biomarkers before, during and after treatment with PF-00299804 and attempt to correlate with EGFR variant III mutation status, EGFR amplification and histopathological changes [ Time Frame: 8-11 months ]
- To assess the relationship between pharmacokinetic parameters and molecular changes detected in OCC tumor specimens [ Time Frame: 8-11 months ]
- To assess the safety and tolerability of pre-operative PF-00299804 [ Time Frame: 8-11 months ]
- To quantitatively assess the effect of PF-00299804 on tumorigenic cells expressing CD44+/Lin- markers in paired OCC tumor specimens [ Time Frame: 8-11 months ]
Information By: University Health Network, Toronto
Dates:
Date Received: May 3, 2010
Date Started: May 2010
Date Completion:
Last Updated: July 8, 2015
Last Verified: July 2015