Gefitinib in Treating Patients With Malignant Mesothelioma

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...

Date First Received: October 11, 2001

Last Updated: July 23, 2008

Verified by: National Cancer Institute (NCI), September 2006

Clinical Trial Phase: Phase 2 | Start Date: August 2001

Overall Status: Completed

Brief Summary

Official Title: “A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma”

Condition Keyword(s):

Intervention(s):

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.

Study Type: Interventional

Study Design: Treatment

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: gefitinib

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Cancer and Leukemia Group B

Overall Clinical Trial Officials and Contacts

Ramaswamy Govindan, MD Study Chair Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis  

Related Publications

Citations Reporting 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.

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00025207

Study ID Number: CDR0000068938

ClinicalTrials.gov Identifier: NCT00025207

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database

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