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Completed

NCT Number: NCT00030498

Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction

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

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Key information

Conditions

Adult Anaplastic Astrocytoma Adenocarcinoma Adenoma Adnexal Diseases 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 Diseases Anus Neoplasms Astrocytoma Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Carcinoma, Squamous Cell Central Nervous System Diseases Central Nervous System Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Cranial Nerve Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Ependymoma Esophageal Diseases Esophageal Neoplasms Esthesioneuroblastoma, Olfactory Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glioblastoma Glioma Glioma, Subependymal Gliosarcoma Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Breast Cancer Male Urogenital Diseases Mesothelioma Mesothelioma, Malignant Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Olfactory Nerve Diseases Oligodendroglioma Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pleural Neoplasms Prostatic Diseases Prostatic Neoplasms Rectal Diseases 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 Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck 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 Stomatognathic Diseases Thoracic Neoplasms Unspecified Adult Solid Tumor, Protocol Specific Untreated Metastatic Squamous Neck Cancer With Occult Primary Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed solid tumor, including gliomas and the following epithelial malignancies:
  • Non-small cell lung
  • Mesothelioma
  • Breast
  • Head and neck
  • Esophageal
  • Pancreatic
  • Bladder
  • Prostate
  • Ovarian
  • Anal
  • Colorectal carcinoma
  • Cervical carcinoma
  • Hepatocellular carcinoma
  • Metastatic or unresectable disease
  • Standard curative or palliative therapy does not exist or is no longer effective
  • Epidermal growth factor receptor (EGFR) positive
  • Hepatic or renal dysfunction defined as one of the following:
  • Direct bilirubin 1.0-7.0 mg/dL with any AST
  • Albumin less than 2.5 g/dL
  • Creatinine 2.5-5.0 mg/dL
  • Brain metastases allowed provided patient is asymptomatic, previously treated, has stable disease for at least 2 months, and is not currently receiving steroid therapy
  • Hormone receptor status:
  • Not specified
  • Male or female
  • Performance status - ECOG 0-2
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • See Disease Characteristics
  • No evidence of biliary obstruction
  • See Disease Characteristics
  • No evidence of renal obstruction
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No gastrointestinal tract disease that would preclude ability to take oral medications
  • No requirement for IV alimentation
  • No active peptic ulcer disease
  • No prior corneal abnormalities (e.g., dry eye syndrome or Sjogren's syndrome)
  • No prior congenital abnormality (e.g., Fuch's dystrophy)
  • No prior abnormal slit-lamp exam using a vital dye (e.g., fluorescein or Bengal-Rose)
  • No prior abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • At least 4 weeks since prior chemotherapy (6 weeks for melphalan or mitomycin)
  • No prior nitrosoureas
  • See Disease Characteristics
  • No concurrent steroids
  • At least 4 weeks since prior radiotherapy
  • At least 4 weeks since prior major surgery
  • No prior surgical procedures affecting absorption
  • No prior EGFR-targeting therapies, including gefitinib or Imclone C-225
  • At least 3 months since prior suramin
  • More than 7 days since prior grapefruit juice
  • More than 7 days since other prior CYP3A4 inhibitors
  • No concurrent grapefruit juice
  • No concurrent CYP3A4 inducers, substrates, or other inhibitors
  • No concurrent medications known to affect hepatic or renal function, including antiseizure medication or nonsteroidal anti-inflammatory agents
  • No concurrent combination anti-retroviral therapy for HIV-positive patients

Treatment and study plan

Erlotinib Hydrochloride

Drug

Given orally

Other names: CP-358,774, erlotinib, OSI-774

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities

    Time frame: Within the first 4 weeks treatment

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction

Important dates

Study start
2001
Primary completion
2007
First posted
Jan 27, 2003
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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