search
Back to results

Gefitinib in Treating Patients With Malignant Mesothelioma

Primary Purpose

Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gefitinib
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Malignant Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer and Leukemia Group B

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (gefitinib)

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of patients who remain failure-free
Kaplan-Meier's product limit estimator and curves will be used.

Secondary Outcome Measures

Tumor response rate
An exact binomial confidence interval will be generated.
Toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
For each type of toxicity experienced, the frequency of reported toxicity will be summarized by the most severe grade.
Overall survival
Kaplan-Meier's product limit estimator and curves will be used.
Failure-free survival within patient subgroups defined in terms of epidermal growth factor receptor (EGFR) overexpression and cyclooxygenase-2 (COX-2) expression
An exact binomial confidence interval will be generated.

Full Information

First Posted
October 11, 2001
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00025207
Brief Title
Gefitinib in Treating Patients With Malignant Mesothelioma
Official Title
A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (gefitinib)
Arm Type
Experimental
Arm Description
Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
gefitinib
Other Intervention Name(s)
Iressa, ZD 1839
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Percentage of patients who remain failure-free
Description
Kaplan-Meier's product limit estimator and curves will be used.
Time Frame
Time between the initiation of treatment and initial failure (disease progression, relapse, death), assessed up to 3 months
Secondary Outcome Measure Information:
Title
Tumor response rate
Description
An exact binomial confidence interval will be generated.
Time Frame
Up to 4 years
Title
Toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Description
For each type of toxicity experienced, the frequency of reported toxicity will be summarized by the most severe grade.
Time Frame
Up to 4 years
Title
Overall survival
Description
Kaplan-Meier's product limit estimator and curves will be used.
Time Frame
Up to 4 years
Title
Failure-free survival within patient subgroups defined in terms of epidermal growth factor receptor (EGFR) overexpression and cyclooxygenase-2 (COX-2) expression
Description
An exact binomial confidence interval will be generated.
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramaswamy Govindan
Organizational Affiliation
Cancer and Leukemia Group B
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer and Leukemia Group B
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gefitinib in Treating Patients With Malignant Mesothelioma

We'll reach out to this number within 24 hrs