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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00498953 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with radiation therapy, with or without lapatinib, before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed or eliminate the need for surgery.
PURPOSE: This phase I/II trial is studying the side effects and best dose of combination chemotherapy given together with radiation therapy with or without lapatinib and to see how well it works in treating patients with locally advanced cancer of the larynx or hypopharynx.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: fludeoxyglucose F 18 Drug: fluorouracil Drug: lapatinib ditosylate Procedure: conventional surgery Procedure: cytogenetic analysis Procedure: fluorescence in situ hybridization Procedure: immunohistochemistry staining method Procedure: in situ hybridization Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: polymerase chain reaction Procedure: radiation therapy Procedure: reverse transcriptase-polymerase chain reaction |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Phase I/II Study on Induction Chemotherapy Followed by Chemoradiation With or Without Lapatinib, a Dual EGFR/ErbB2 Kinase Inhibitor, in Patients With Locally Advanced Larynx and Hypopharynx Squamous Cell Carcinoma |
Estimated Enrollment: | 133 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation phase I study followed by a randomized phase II study. Patients are stratified by institution and EGFR status (negative vs positive).
Phase I:
Phase II: Patients are randomized to 1 of 2 treatment arms.
In both phases, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients with node-positive disease (initially) undergo tumor and blood sample collection for biological studies. Samples are analyzed for ErbB-related activation via immunohistochemistry, in situ hybridization, and PCR/sequencing of genes/proteins, to detect DNA amplification and polysomy (for AKT, ErbB2, EGFR) and genomic losses (for PTEN) via FISH, and the ratio between EGFR and EGFRvIII via QRT-PCR. Patients with node-positive disease undergo at least elective neck dissection to evaluate the negative predictive value of PET scanning.
Patients are followed every 3 months for one year and then every 6 months thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed squamous cell carcinoma of the larynx or hypopharynx
PATIENT CHARACTERISTICS:
No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
More than 10 days since prior and no concurrent CYP3A4 inducers, including the following:
More than 10 days since prior and no concurrent CYP3A4 inhibitors, including the following:
Study ID Numbers: | CDR0000553410, EORTC-24051, EUDRACT-2006-002667-33, GSK-EORTC-24051 |
Study First Received: | July 10, 2007 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00498953 |
Health Authority: | United States: Federal Government |
stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx |
Squamous cell carcinoma Lapatinib Laryngeal Neoplasms Carboplatin Carcinoma Epidermoid carcinoma Docetaxel Cisplatin |
Head and Neck Neoplasms Fluorouracil Carcinoma, squamous cell Laryngeal carcinoma Hypopharyngeal cancer Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |