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Clinical Trial Summary

Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of erlotinib in patients with solid tumors and hepatic or renal dysfunction.

II. Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to hepatic or renal dysfunction (albumin less than 2.5 g/dL, direct bilirubin less than 1.0 mg/dL, any AST, and creatinine normal vs direct bilirubin 1.0-7.0 mg/dL, any AST, and creatinine normal vs creatinine 2.5-5.0 mg/dL, albumin 2.5 g/dL or greater, AST less than 3 times upper limit of normal, and direct bilirubin less than 1.0 mg/dL).

Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

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. Once the MTD is determined, at least 6 evaluable patients are treated at that dose. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Ependymoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Brain Stem Glioma
  • Adult Diffuse Astrocytoma
  • Adult Ependymoblastoma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Mixed Glioma
  • Adult Myxopapillary Ependymoma
  • Adult Oligodendroglioma
  • Adult Pilocytic Astrocytoma
  • Adult Primary Hepatocellular Carcinoma
  • Adult Subependymoma
  • Advanced Adult Primary Liver Cancer
  • Advanced Malignant Mesothelioma
  • Anus Neoplasms
  • Astrocytoma
  • Breast Neoplasms
  • Breast Neoplasms, Male
  • Carcinoma
  • Carcinoma, Adenoid Cystic
  • Carcinoma, Basal Cell
  • Carcinoma, Hepatocellular
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Ependymoma
  • Esophageal Neoplasms
  • Esthesioneuroblastoma, Olfactory
  • Glioblastoma
  • Glioma
  • Gliosarcoma
  • Granuloma
  • Laryngeal Diseases
  • Laryngeal Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms
  • Male Breast Cancer
  • Mesothelioma
  • Nasopharyngeal Neoplasms
  • Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Oligodendroglioma
  • Oropharyngeal Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Papilloma
  • Paranasal Sinus Neoplasms
  • Prostatic Neoplasms
  • Rectal Neoplasms
  • Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
  • Recurrent Adult Brain Tumor
  • Recurrent Adult Primary Liver Cancer
  • Recurrent Anal Cancer
  • Recurrent Basal Cell Carcinoma of the Lip
  • Recurrent Bladder Cancer
  • Recurrent Breast Cancer
  • Recurrent Cervical Cancer
  • Recurrent Colon Cancer
  • Recurrent Esophageal Cancer
  • Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Lymphoepithelioma of the Nasopharynx
  • Recurrent Lymphoepithelioma of the Oropharynx
  • Recurrent Malignant Mesothelioma
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
  • Recurrent Non-small Cell Lung Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Pancreatic Cancer
  • Recurrent Prostate Cancer
  • Recurrent Rectal Cancer
  • Recurrent Salivary Gland Cancer
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Nasopharynx
  • Recurrent Squamous Cell Carcinoma of the Oropharynx
  • Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Verrucous Carcinoma of the Larynx
  • Recurrent Verrucous Carcinoma of the Oral Cavity
  • Salivary Gland Neoplasms
  • Stage II Esophageal Cancer
  • Stage II Pancreatic Cancer
  • Stage III Esophageal Cancer
  • Stage III Pancreatic Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage IV Anal Cancer
  • Stage IV Basal Cell Carcinoma of the Lip
  • Stage IV Bladder Cancer
  • Stage IV Breast Cancer
  • Stage IV Colon Cancer
  • Stage IV Esophageal Cancer
  • Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
  • Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
  • Stage IV Lymphoepithelioma of the Nasopharynx
  • Stage IV Lymphoepithelioma of the Oropharynx
  • Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
  • Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Pancreatic Cancer
  • Stage IV Prostate Cancer
  • Stage IV Rectal Cancer
  • Stage IV Salivary Gland Cancer
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IV Squamous Cell Carcinoma of the Oropharynx
  • Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IV Verrucous Carcinoma of the Larynx
  • Stage IV Verrucous Carcinoma of the Oral Cavity
  • Stage IVA Cervical Cancer
  • Stage IVB Cervical Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Untreated Metastatic Squamous Neck Cancer With Occult Primary
  • Urinary Bladder Neoplasms
  • Uterine Cervical Neoplasms

NCT number NCT00030498
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date December 2001

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