NCT00030498

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

5.6 years

First QC Date

February 14, 2002

Last Update Submit

January 15, 2013

Conditions

Adult Anaplastic AstrocytomaAdult Anaplastic EpendymomaAdult Anaplastic OligodendrogliomaAdult Brain Stem GliomaAdult Diffuse AstrocytomaAdult EpendymoblastomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Mixed GliomaAdult Myxopapillary EpendymomaAdult OligodendrogliomaAdult Pilocytic AstrocytomaAdult Primary Hepatocellular CarcinomaAdult SubependymomaAdvanced Adult Primary Liver CancerAdvanced Malignant MesotheliomaMale Breast CancerRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Adult Brain TumorRecurrent Adult Primary Liver CancerRecurrent Anal CancerRecurrent Basal Cell Carcinoma of the LipRecurrent Bladder CancerRecurrent Breast CancerRecurrent Cervical CancerRecurrent Colon CancerRecurrent Esophageal CancerRecurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityRecurrent Inverted Papilloma of the Paranasal Sinus and Nasal CavityRecurrent Lymphoepithelioma of the NasopharynxRecurrent Lymphoepithelioma of the OropharynxRecurrent Malignant MesotheliomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Pancreatic CancerRecurrent Prostate CancerRecurrent Rectal CancerRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage II Esophageal CancerStage II Pancreatic CancerStage III Esophageal CancerStage III Pancreatic CancerStage IIIB Non-small Cell Lung CancerStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Anal CancerStage IV Basal Cell Carcinoma of the LipStage IV Bladder CancerStage IV Breast CancerStage IV Colon CancerStage IV Esophageal CancerStage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage IV Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage IV Lymphoepithelioma of the NasopharynxStage IV Lymphoepithelioma of the OropharynxStage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Pancreatic CancerStage IV Prostate CancerStage IV Rectal CancerStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IV Verrucous Carcinoma of the LarynxStage IV Verrucous Carcinoma of the Oral CavityStage IVA Cervical CancerStage IVB Cervical CancerUnspecified Adult Solid Tumor, Protocol SpecificUntreated Metastatic Squamous Neck Cancer With Occult Primary

Outcome Measures

Primary Outcomes (1)

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

    Within the first 4 weeks treatment

Study Arms (1)

Treatment (erlotinib hydrochloride)

EXPERIMENTAL

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

Drug: erlotinib hydrochlorideOther: laboratory biomarker analysis

Interventions

erlotinib hydrochlorideDRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774
Treatment (erlotinib hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (erlotinib hydrochloride)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +48 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

AstrocytomaEpendymomaOligodendrogliomaNeuroectodermal Tumors, PrimitiveGlioblastomaGliosarcomaGliomaCarcinoma, HepatocellularGlioma, SubependymalBreast Neoplasms, MaleBrain NeoplasmsAnus NeoplasmsUrinary Bladder NeoplasmsBreast NeoplasmsUterine Cervical NeoplasmsColonic NeoplasmsEsophageal NeoplasmsEsthesioneuroblastoma, OlfactoryMesothelioma, MalignantCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian EpithelialPancreatic NeoplasmsProstatic NeoplasmsRectal NeoplasmsSalivary Gland NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAdenocarcinomaCarcinomaLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralOlfactory Nerve DiseasesCranial Nerve DiseasesMesotheliomaAdenomaNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsPleural NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesCarcinoma, Squamous Cell

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Antonius Miller

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

December 1, 2001

Primary Completion

July 1, 2007

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)