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Gefitinib in Treating Patients With Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00025207
Recruitment Status : Completed
First Posted : September 10, 2003
Last Update Posted : January 17, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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

Condition or disease Intervention/treatment Phase
Advanced Malignant Mesothelioma Epithelial Mesothelioma Recurrent Malignant Mesothelioma Sarcomatous Mesothelioma Drug: gefitinib Other: laboratory biomarker analysis Phase 2

Detailed Description:

OBJECTIVES:

I. Determine the activity of gefitinib, in terms of failure-free survival, in patients with malignant mesothelioma.

II. Determine the response rate in patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine the overall survival of patients treated with this drug. V. Determine whether overexpression of epidermal growth factor receptor and expression of cyclo-oxygenase-2 can predict the effectiveness of this drug in these patients.

OUTLINE: This is a multicenter study.

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

Patients are followed every 2 months for 1 year and then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 7-10 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma
Study Start Date : September 2001
Actual Primary Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
Drug Information available for: Gefitinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (gefitinib)
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: gefitinib
Given orally
Other Names:
  • Iressa
  • ZD 1839

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients who remain failure-free [ Time Frame: Time between the initiation of treatment and initial failure (disease progression, relapse, death), assessed up to 3 months ]
    Kaplan-Meier's product limit estimator and curves will be used.


Secondary Outcome Measures :
  1. Tumor response rate [ Time Frame: Up to 4 years ]
    An exact binomial confidence interval will be generated.

  2. Toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 [ Time Frame: Up to 4 years ]
    For each type of toxicity experienced, the frequency of reported toxicity will be summarized by the most severe grade.

  3. Overall survival [ Time Frame: Up to 4 years ]
    Kaplan-Meier's product limit estimator and curves will be used.

  4. Failure-free survival within patient subgroups defined in terms of epidermal growth factor receptor (EGFR) overexpression and cyclooxygenase-2 (COX-2) expression [ Time Frame: Up to 4 years ]
    An exact binomial confidence interval will be generated.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Performance status - CTC 0-1
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

  • No other concurrent active malignancy except nonmelanoma skin cancer

    • Disease considered not currently active if completely treated with less than a 30% risk for relapse
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No prior epidermal growth factor receptor-inhibitor therapy
  • Prior intrapleural cytotoxic or sclerosing agents (including bleomycin) allowed
  • No prior systemic cytotoxic chemotherapy for malignant mesothelioma
  • No concurrent chemotherapy
  • At least 1 week since prior CYP3A4 inducers (e.g., dexamethasone, glucocorticoids, progesterone)
  • No concurrent CYP3A4 inducers (e.g., dexamethasone)
  • No concurrent hormonal therapy (e.g., tamoxifen) except steroids for adrenal failure or hormones for non disease-related conditions (e.g., insulin for diabetes)
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy, including for palliation
  • See Disease Characteristics
  • At least 2 weeks since prior major surgery
  • At least 1 week since other prior CYP3A4 inducers (e.g., carbamazepine, ethosuximide, griseofulvin, nafcillin, nelfinavir mesylate, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rofecoxib, St. John's Wort, sulfadimidine, sulfinpyrazone, or troglitazone)
  • No other concurrent CYP3A4 inducers
  • No concurrent CYP3A4 substrates or inhibitors
  • No other concurrent investigational agent
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent chlorpromazine, amiodarone, or chloroquine
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025207


Locations
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United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ramaswamy Govindan Cancer and Leukemia Group B
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025207    
Other Study ID Numbers: NCI-2012-02414
CLB-30101
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000068938 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 10, 2003    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action