NCT00025207

Brief Summary

Phase II trial to study the effectiveness of gefitinib in treating patients who have malignant mesothelioma. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of malignant mesothelioma

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

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

September 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

September 10, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

4.4 years

First QC Date

October 11, 2001

Last Update Submit

January 15, 2013

Conditions

Advanced Malignant MesotheliomaEpithelial MesotheliomaRecurrent Malignant MesotheliomaSarcomatous Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who remain failure-free

    Kaplan-Meier's product limit estimator and curves will be used.

    Time between the initiation of treatment and initial failure (disease progression, relapse, death), assessed up to 3 months

Secondary Outcomes (4)

  • Tumor response rate

    Up to 4 years

  • Toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0

    Up to 4 years

  • Overall survival

    Up to 4 years

  • Failure-free survival within patient subgroups defined in terms of epidermal growth factor receptor (EGFR) overexpression and cyclooxygenase-2 (COX-2) expression

    Up to 4 years

Study Arms (1)

Treatment (gefitinib)

EXPERIMENTAL

Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Drug: gefitinibOther: laboratory biomarker analysis

Interventions

gefitinibDRUG

Given orally

Also known as: Iressa, ZD 1839
Treatment (gefitinib)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (gefitinib)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed malignant mesothelioma that is not amenable to curative surgery or radiotherapy
  • Epithelial, sarcomatoid, or mixed subtype
  • Any site of origin (including, but not limited to, the pleura, peritoneum, pericardium, or tunica vaginalis) allowed
  • Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter) as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
  • Must be outside prior radiation port
  • Lesions not considered measurable include the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses not confirmed and followed by imaging techniques
  • Cystic lesions
  • No known brain metastases
  • +34 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

Mesothelioma, MalignantSolitary Fibrous Tumor, Pleural

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract DiseasesSolitary Fibrous TumorsNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ramaswamy Govindan

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2001

First Posted

September 10, 2003

Study Start

September 1, 2001

Primary Completion

February 1, 2006

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)