Erlotinib In Treating Patients With Solid Tumors And Liver Or Kidney Dysfunction

Study Overview

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

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.

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
Male Breast Cancer
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
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

DRUG: erlotinib hydrochloride
OTHER: laboratory biomarker analysis

NCI-2012-01868
CALGB-60101
U10CA031946 (U.S. NIH Grant/Contract)
CDR0000069170 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-02-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-01-15
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-01-16
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2013-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (erlotinib hydrochloride) Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.	DRUG: erlotinib hydrochloride Given orally OTHER: laboratory biomarker analysis Correlative studies

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (erlotinib hydrochloride)

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

DRUG: erlotinib hydrochloride

Given orally

OTHER: laboratory biomarker analysis

Correlative studies

Primary Outcome Measures	Measure Description	Time Frame
Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities		Within the first 4 weeks treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Antonius Miller, Cancer and Leukemia Group B

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Resources

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Clinical Trial Record