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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00049166 |
Purpose
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with radiation therapy with or without cisplatin may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with radiation therapy with or without cisplatin in treating patients who have advanced mouth or throat cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: OSI-774 Plus Standard Fractionation Radiation and Low dose Daily Cisplatin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study Of OSI-774 In Combination With Intensity-Modulated Radiation (IMRT) Therapy In Patients With Oral Cavity Or Oropharyngeal Cancer Stage II Or III And In Combination With Standard Fractionation Radiation Therapy And Low Dose Daily Cisplatin In Patients With Oral Cavity Or Oropharyngeal Cancer Stage III And IV |
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2002 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of erlotinib. Patients are assigned to 1 of 2 regimens according to disease stage.
Patients in both regimens continue to receive erlotinib until the last day of IMRT (patients already in the maintenance phase of this study as of 5/11/04 continue to receive erlotinib once daily for up to 2 years) in the absence of disease progression or unacceptable toxicity.
In both regimens, cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 30 days and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 24-48 patients (12-24 per regimen) will be accrued for this study within 6-24 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the oral cavity (OC) or oropharynx (OP)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Ophthalmic
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Louisiana | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70118 | |
| New Orleans Cancer Institute at Memorial Medical Center | |
| New Orleans, Louisiana, United States, 70115 | |
| Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane Cancer Center at Tulane University Hospital and Clinic | |
| New Orleans, Louisiana, United States, 70112-2699 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Pennsylvania | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Study Chair: | Maura Gillison, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Responsible Party: | Charles Raines, CRNP, MSN, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT00049166 History of Changes |
| Other Study ID Numbers: | JHOC-J0174, CDR0000257942, U01CA070095, P30CA006973, JHOC-20020723, JHOC-J0174, NCI-5375 |
| Study First Received: | November 12, 2002 |
| Last Updated: | August 15, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
stage II squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the lip and oral cavity |
stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx |
|
Head and Neck Neoplasms Oropharyngeal Neoplasms Neoplasms by Site Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Cisplatin |
Erlotinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |