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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00042835 |
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 work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and radiation therapy with combination chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining erlotinib and radiation therapy with combination chemotherapy in treating patients who have inoperable stage III non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: erlotinib hydrochloride Drug: etoposide Drug: paclitaxel Procedure: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Of OSI-774 (NSC #718781)-Based Multimodality Therapy For Inoperable Stage III Non Small Cell Lung Cancer |
Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of erlotinib. Patients are assigned to 1 of 2 treatment groups.
In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib during concurrent chemoradiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. At least 12 patients from each group are treated at the MTD.
Patients are followed at 8 weeks.
PROJECTED ACCRUAL: A total of 24-48 patients (12-24 per treatment group) will be accrued for this study within 6-12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
No disease invasion of a vertebral body
Pleural effusion that is transudative, cytologically negative, and non-bloody allowed if the tumor can be encompassed in a reasonable field of radiotherapy
Measurable or evaluable disease
Evaluable disease includes lesions apparent on CXR or CT scan that are:
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
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
Maywood, Illinois, United States, 60153-5589 | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Decatur Memorial Hospital Cancer Care Institute | |
Decatur, Illinois, United States, 62526 | |
Evanston Northwestern Health Care - Evanston Hospital | |
Evanston, Illinois, United States, 60201-1781 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
Oncology/Hematology Associates of Central Illinois, P.C. | |
Peoria, Illinois, United States, 61615-7828 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Fort Wayne Medical Oncology and Hematology | |
Fort Wayne, Indiana, United States, 46885-5099 | |
United States, Michigan | |
Oncology Care Associates, PLLC | |
Saint Joseph, Michigan, United States, 49085 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | |
Milwaukee, Wisconsin, United States, 53226 |
Study Chair: | Ann M. Mauer, MD | University of Chicago |
Study ID Numbers: | CDR0000069474, UCCRC-11432, NCI-5411 |
Study First Received: | August 5, 2002 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00042835 |
Health Authority: | United States: Federal Government |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer squamous cell lung cancer |
large cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma, Bronchiolo-Alveolar Carboplatin Etoposide phosphate Carcinoma Docetaxel Adenocarcinoma of lung |
Cisplatin Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Adenocarcinoma Etoposide Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |