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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00063895 |
Purpose
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I/II trial is studying the side effects of erlotinib and to see how well it works in treating patients with metastatic or unresectable non-small cell lung cancer, ovarian cancer, or squamous cell carcinoma (cancer) of the head and neck.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Head and Neck Cancer Lung Cancer Ovarian Cancer |
Drug: erlotinib hydrochloride |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Pharmacogenetic and Pharmacodynamic Study of Erlotinib (OSI-774) Toxicity in Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck |
| Study Start Date: | July 2003 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to length of CA dinucleotide repeat polymorphism (short vs medium vs long).
Patients receive oral erlotinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 20 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following histologically or cytologically confirmed malignancies:
No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Ophthalmic
No significant ophthalmologic abnormalities*, including any of the following:
Disorders that increase the risk for epithelium-related complications, including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| Study Chair: | Charles M. Rudin, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000304628, JHOC-J0384, UCCRC-12202A, NCI-5948 |
| Study First Received: | July 8, 2003 |
| Last Updated: | August 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00063895 History of Changes |
| Health Authority: | United States: Federal Government |
|
drug/agent toxicity by tissue/organ stage IV non-small cell lung cancer recurrent non-small cell lung cancer recurrent ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer stage IV salivary gland cancer salivary gland squamous cell carcinoma recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx |
stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage III squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage III salivary gland cancer stage III ovarian epithelial cancer |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Protein Kinase Inhibitors Genital Diseases, Female Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Neoplasms, Squamous Cell Endocrine Gland Neoplasms Erlotinib Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Pharmacologic Actions Carcinoma Adnexal Diseases Neoplasms Lung Diseases Head and Neck Neoplasms Carcinoma, Squamous Cell Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |