Clinical trial · Interventional
Gefitinib in Treating Patients With Malignant Mesothelioma
A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma
NCT00025207CI-TRIAL-00008964completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Epithelial Mesothelioma | Epithelioid Mesothelioma | ALIAS | 0.90 |
| Recurrent Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Sarcomatous Mesothelioma | Pleural Solitary Fibrous Tumor | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (gefitinib)
- 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.
- interventionNames
- Drug: gefitinib
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Percentage of patients who remain failure-free
- timeFrame
- Time between the initiation of treatment and initial failure (disease progression, relapse, death), assessed up to 3 months
- description
- Kaplan-Meier's product limit estimator and curves will be used.
Secondary outcomes (4)
- measure
- Tumor response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 chloroquineReferences
Publications (0)
Data not yet available
No reference posted for this study.