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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00779389 |
The central hypothesis to be tested in this study is that dual blockade of EGFR and Src pathways or proteins are distinct compared to inhibition of either kinase alone in head and neck and lung cancers.
Condition | Intervention |
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Head and Neck Cancer Non Small Cell Lung Cancer |
Drug: Erlotinib Drug: Dasatinib plus Placebo Drug: Erlotinib plus Dasatinib Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Biomarker Modulation by Inhibition of EGFR and/or Src Family Kinases Using Erlotinib and Dasatinib in Head and Neck Lung Cancers |
Estimated Enrollment: | 56 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental
Erlotinib 150 mg
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Drug: Erlotinib
Erlotinib 150mg will be taken once a day for 14-21days.
Drug: Erlotinib
Erlotinib 150 mg for 14-21 days.
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Arm B: Experimental
Dasatinib + placebo
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Drug: Dasatinib plus Placebo
Dasatinib (100 mg) once a day for 14-21 days.
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Arm C: Experimental
Erlotinib (150 mg) plus Dasatinib (100 mg) for 14-21 days.
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Drug: Erlotinib plus Dasatinib
Erlotinib (150 mg PO qD) plus Dasatinib (100 mg PO qD) 14-21 days
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Arm D: Placebo Comparator
Placebo for 14-21 days
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Drug: Placebo
Placebo for 14-21 days.
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Background Head and neck squamous cell carcinoma (HNSCC) constitutes 3% of all malignancies and is the sixth most common malignancy worldwide. There will be an estimated 40,000 new cases and 11,000 deaths in the United States in 2007 and approximately 500,000 cases worldwide yearly [1]. Squamous cell carcinoma accounts for at least 90% of all head and neck cancers. Surgical resection remains a standard treatment for patients with resectable HNSCC. For patients with high risk of local or distant relapse, radiation therapy (RT) alone, or in combination with chemotherapy, is given after surgery to improve loco-regional control and overall survival. Moreover, surgery often represents the only curative option in patients who relapase locoregionally. Non-small cell lung cancer (NSCLC) is the leading cause of death worldwide. NSCLC is infrequently diagnosed when the cancer can be eradicated with surgical extirpation.
Specific Aims
Subject population Patients will be accrued from head and neck and lung cancer patients who are surgical candidates. Surgery will be the primary curative treatment for patients enrolled in this study. Patients should not require any standard induction treatment prior to surgery. Surgery will have to be the best treatment option as determined by the treating physician. Therefore, we will not be delaying chemoradiotherapy or other curative treatment. We plan to include any stage of HNSCC or NSCLC that will be managed by primary surgery. If surgery is unexpectedly cancelled, the patient will be removed from the study unless there is an accessible lesion for biopsy. Ideally, the pre-treatment biopsy and the intraoperative sample will be obtained from the same site (when there are multiple lesions). Please see Section 3.0 for detailed eligibility criteria.
Treatment Plan The study drug or placebo will be taken for 14-21 days, and will be discontinued one day prior to planned surgical resection. If surgery is delayed, the study drug or placebo will be continued until one day prior to surgery, for up to a maximum of 28 days. Fourteen days is the minimum treatment for the patients to be evaluated. The interval between the last dose of experimental drug and surgery will be 12-36 hours. Please see Section 5.0 for treatment plan details. If the combination of erlotinib and dasatinib results in toxicity leading to a delay in surgery, the study will be terminated.
Statistical design and sample size This is a 4-arm randomized trial that is intended to estimate the effects of short-term preoperative therapy with EGFR and Src inhibitors upon a panel of biomarkers. The 4 treatment arms are erlotinib, dasatinib, their combination, and a placebo. We anticipate accruing 56 patients (14 patients per arm).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women of childbearing potential (WOCBP) must have:
Exclusion Criteria:
Cardiac Symptoms; any of the following should be considered for exclusion:
Concurrent medical condition which may increase the risk of toxicity, including:
* Pleural or pericardial effusion of any grade
History of significant bleeding disorder unrelated to cancer, including:
Concomitant Medications, any of the following should be considered for exclusion:
* Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
Women who:
Principal Investigator: | Jennifer R Grandis, MD | University of Pittsburgh |
Principal Investigator: | Jennifer R Grandis, MD | University of Pittsburgh |
Principal Investigator: | Jennifer R Grandis, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh Medical Center ( Jennifer Grandis, MD ) |
Study ID Numbers: | 07-124 |
Study First Received: | October 22, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779389 |
Health Authority: | United States: Institutional Review Board |
Head and Neck cancer |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Dasatinib |
Lung Diseases Head and Neck Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |