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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00397384 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib and cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with cetuximab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or colorectal cancer.
Condition | Intervention | Phase |
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Cancer |
Drug: cetuximab Drug: erlotinib hydrochloride |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase I/II Clinical and Biological Evaluation of Combined EGFR Blockade With Erlotinib and Cetuximab in Patients With Advanced Cancer (Phase I) or Advanced Colorectal Cancer (Phase II) |
Estimated Enrollment: | 55 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, nonrandomized, dose-escalation study of erlotinib hydrochloride followed by a phase II, open-label study.
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following:
Colorectal adenocarcinoma** meeting the following criteria:
KRAS wild type by PCR assay or directed sequencing of KRAS exon and codons 12 and 13
Received ≥ 1 prior systemic regimen for advanced/metastatic disease, including fluorouracil and leucovorin calcium and either oxaliplatin or irinotecan hydrochloride**
Measurable disease**, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
History of brain metastases allowed provided ≥ 1 of the following criteria are met:
NOTE: **Phase II only
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center - Cool Springs | |
Nashville, Tennessee, United States, 37064 | |
Vanderbilt-Ingram Cancer Center at Franklin | |
Nashville, Tennessee, United States, 37064 | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 |
Study Chair: | Laura Goff, MD | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000511880, VU-VICC-GI-0622, NCI-6980 |
Study First Received: | November 8, 2006 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00397384 |
Health Authority: | United States: Food and Drug Administration |
adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer adenocarcinoma of the rectum recurrent non-small cell lung cancer stage IV non-small cell lung cancer metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx stage IV basal cell carcinoma of the lip stage IV mucoepidermoid carcinoma of the oral cavity |
stage IV verrucous carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity stage IV squamous cell carcinoma of the lip and oral cavity metastatic squamous neck cancer with occult primary stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity stage IV inverted papilloma of the paranasal sinus and nasal cavity stage IV midline lethal granuloma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV salivary gland cancer recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx |
Thoracic Neoplasms Rectal Neoplasms Pancreatic Neoplasms Colonic Diseases Rectal Diseases Dental Caries Carcinoma, Adenoid Cystic Lung Neoplasms Metastatic squamous neck cancer with occult primary Laryngeal carcinoma Salivary Gland Diseases Rectal cancer Erlotinib Non-small cell lung cancer Digestive System Neoplasms |
Carcinoma, Basal Cell Stomach cancer Gall bladder cancer Carcinoma Lung Diseases Gastrointestinal Neoplasms Carcinoid Tumor Esophageal Diseases Gallbladder Neoplasms Carcinoma, Squamous Cell Anus Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Leiomyosarcoma Gastrointestinal Diseases |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |