- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00030498
Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction
Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction
Study Overview
Status
Conditions
- Recurrent Prostate Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- Recurrent Bladder Cancer
- Stage IV Bladder Cancer
- Recurrent Pancreatic Cancer
- Stage III Pancreatic Cancer
- Stage IV Pancreatic Cancer
- Male Breast Cancer
- Stage IV Breast Cancer
- Stage IV Ovarian Epithelial Cancer
- Stage IIIB Non-small Cell Lung Cancer
- Stage IV Prostate Cancer
- Recurrent Breast Cancer
- Recurrent Ovarian Epithelial Cancer
- Stage IV Colon Cancer
- Stage IV Rectal Cancer
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Adult Anaplastic Astrocytoma
- Adult Anaplastic Ependymoma
- Adult Anaplastic Oligodendroglioma
- Adult Diffuse Astrocytoma
- Adult Giant Cell Glioblastoma
- Adult Glioblastoma
- Adult Gliosarcoma
- Adult Mixed Glioma
- Adult Myxopapillary Ependymoma
- Adult Oligodendroglioma
- Adult Pilocytic Astrocytoma
- Adult Subependymoma
- Stage II Pancreatic Cancer
- Recurrent Metastatic Squamous Neck Cancer With Occult Primary
- 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 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
- Recurrent Adult Brain Tumor
- Recurrent Non-small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer
- Advanced Adult Primary Liver Cancer
- Recurrent Adult Primary Liver Cancer
- Adult Primary Hepatocellular Carcinoma
- Adult Brain Stem Glioma
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
- Recurrent Basal Cell Carcinoma of the Lip
- Recurrent Lymphoepithelioma of the Nasopharynx
- Recurrent Lymphoepithelioma of the Oropharynx
- Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IV Basal Cell Carcinoma of the Lip
- Stage IV Lymphoepithelioma of the Nasopharynx
- Stage IV Lymphoepithelioma of the Oropharynx
- Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
- 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 Verrucous Carcinoma of the Larynx
- Stage IV Verrucous Carcinoma of the Oral Cavity
- Recurrent Esophageal Cancer
- Stage IV Esophageal Cancer
- Untreated Metastatic Squamous Neck Cancer With Occult Primary
- Recurrent Cervical Cancer
- Stage IVA Cervical Cancer
- Stage IVB Cervical Cancer
- Stage III Esophageal Cancer
- Adult Ependymoblastoma
- Recurrent Malignant Mesothelioma
- Advanced Malignant Mesothelioma
- Recurrent Anal Cancer
- Stage IV Anal Cancer
- Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- 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 II Esophageal Cancer
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60606
- Cancer and Leukemia Group B
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
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.
|
Correlative studies
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities
Time Frame: Within the first 4 weeks treatment
|
Within the first 4 weeks treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Nervous System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Breast Diseases
- Liver Diseases
- Prostatic Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Esophageal Diseases
- Paranasal Sinus Diseases
- Nose Diseases
- Colorectal Neoplasms
- Cranial Nerve Diseases
- Pancreatic Diseases
- Neoplasm Metastasis
- Neoplasms, Squamous Cell
- Neoplasms, Cystic, Mucinous, and Serous
- Adenoma
- Ovarian Neoplasms
- Nasopharyngeal Neoplasms
- Neoplasms, Basal Cell
- Neuroectodermal Tumors, Primitive, Peripheral
- Salivary Gland Diseases
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Anus Diseases
- Mouth Neoplasms
- Olfactory Nerve Diseases
- Nose Neoplasms
- Neuroblastoma
- Neoplasms
- Uterine Cervical Neoplasms
- Breast Neoplasms
- Head and Neck Neoplasms
- Prostatic Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Nasopharyngeal Carcinoma
- Glioblastoma
- Carcinoma, Hepatocellular
- Recurrence
- Glioma
- Urinary Bladder Neoplasms
- Rectal Neoplasms
- Carcinoma, Adenoid Cystic
- Pancreatic Neoplasms
- Carcinoma, Ovarian Epithelial
- Ependymoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Liver Neoplasms
- Astrocytoma
- Gliosarcoma
- Esophageal Neoplasms
- Granuloma
- Colonic Neoplasms
- Oligodendroglioma
- Mesothelioma
- Mesothelioma, Malignant
- Anus Neoplasms
- Neoplasms, Unknown Primary
- Oropharyngeal Neoplasms
- Neuroectodermal Tumors, Primitive
- Breast Neoplasms, Male
- Salivary Gland Neoplasms
- Esthesioneuroblastoma, Olfactory
- Carcinoma, Basal Cell
- Papilloma
- Laryngeal Neoplasms
- Laryngeal Diseases
- Carcinoma, Verrucous
- Glioma, Subependymal
- Carcinoma, Mucoepidermoid
- Mucoepidermoid Tumor
- Paranasal Sinus Neoplasms
- Papilloma, Inverted
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- NCI-2012-01868
- U10CA031946 (U.S. NIH Grant/Contract)
- CALGB-60101
- CDR0000069170 (REGISTRY: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Prostate Cancer
-
National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Matrix Biomed, Inc.Prostate Oncology SpecialistsNot yet recruitingProstate Cancer Recurrent | Biochemical Recurrent Prostate CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Prostate Cancer | Stage I Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Centre for Probe Development and CommercializationMcDougall Scientific Ltd.CompletedRecurrent Prostate Cancer | Prostate Cancer RecurrentCanada
-
Mayo ClinicRecruitingBiochemically Recurrent Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Oligometastatic Prostate Carcinoma | Recurrent Prostate AdenocarcinomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on laboratory biomarker analysis
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
National Cancer Institute (NCI)Recruiting
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingLynch Syndrome | Recurrent Uterine Corpus Carcinoma | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingRecurrent Uterine Corpus Carcinoma | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingLung Cancer | Radiation Toxicity | Adult Brain TumorUnited States
-
National Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Askin TumorUnited States, Canada, Puerto Rico, Australia, New Zealand, Switzerland
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed