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Gefitinib in Treating Patients With Malignant Mesothelioma
This study has been completed.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025207
  Purpose

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of malignant mesothelioma.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have malignant mesothelioma.


Condition Intervention Phase
Malignant Mesothelioma
Drug: gefitinib
Phase II

MedlinePlus related topics: Cancer Mesothelioma
Drug Information available for: ZD1839
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2001
Detailed Description:

OBJECTIVES:

  • Determine the activity of gefitinib, in terms of failure-free survival, in patients with malignant mesothelioma.
  • Determine the response rate in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the overall survival of patients treated with this drug.
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • CTC 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior epidermal growth factor receptor-inhibitor therapy

Chemotherapy:

  • Prior intrapleural cytotoxic or sclerosing agents (including bleomycin) allowed
  • No prior systemic cytotoxic chemotherapy for malignant mesothelioma
  • No concurrent chemotherapy

Endocrine therapy:

  • 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 nondisease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy, including for palliation

Surgery:

  • See Disease Characteristics
  • At least 2 weeks since prior major surgery

Other:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025207

  Show 52 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Ramaswamy Govindan, MD Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Govindan R, Kratzke RA, Herndon JE 2nd, Niehans GA, Vollmer R, Watson D, Green MR, Kindler HL; Cancer and Leukemia Group B (CALGB 30101). Gefitinib in patients with malignant mesothelioma: a phase II study by the Cancer and Leukemia Group B. Clin Cancer Res. 2005 Mar 15;11(6):2300-4.
Govindan R, Kratzke RA, Herndon JE, et al.: Gefitinib in patients with malignant mesothelioma (MM): a phase II study by the Cancer and Leukemia Group B (CALGB 30101). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2535, 630, 2003.

Study ID Numbers: CDR0000068938, CLB-30101
Study First Received: October 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00025207  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma

Study placed in the following topic categories:
Mesothelioma
Gefitinib
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Mesothelial
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009