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A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma

Phase 2
18 Years
Not Enrolling
Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma

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Trial Information

A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma


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.

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,

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients who remain failure-free

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Ramaswamy Govindan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

Related Keywords:

  • Advanced Malignant Mesothelioma
  • Epithelial Mesothelioma
  • Recurrent Malignant Mesothelioma
  • Sarcomatous Mesothelioma
  • Mesothelioma



Cancer and Leukemia Group B Chicago, Illinois  60606