Clinical trial · Interventional
Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma
NCT00039182CI-TRIAL-00009121completedPhase 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)
Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung
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 |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (erlotinib hydrochloride)
- description
- Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: erlotinib hydrochloride
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Overall survival rate
- timeFrame
- 1 year
- description
- Erlotinib hydrochloride will not be of further interest if the true one-year survival rate is 35% or less, but of considerable interest if 55% or more.
- measure
- RECIST response rate
- timeFrame
- Up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed malignant pleural mesothelioma * Epithelial * Sarcomatous * Biphasic * Measurable or nonmeasurable disease * Not amenable to extrapleural pneumonectomy * No known CNS metastases * Performance status - Zubrod 0-1 * WBC at least 3,000/mm\^3 * Absolute neutrophil 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 or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor) * Creatinine no greater than 2 times ULN * No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation * No active peptic ulcer disease * No intractable nausea or vomiting * Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube * No known history of the following: * Dry eye syndrome * Sjogren's syndrome * Keratoconjunctivitis sicca * Exposure keratopathy * Fuch's dystrophy * Other active disorders of the cornea * Not pregnant or nursing * Fertile patients must use effective contraception * No HIV-positive patients receiving combination antiretroviral therapy * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission * No prior biologic therapy for this tumor * No prior chemotherapy for this tumor * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered * See Disease Characteristics * At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies) * Recovered from prior surgery * No prior surgical procedures affecting absorption * No prior investigational anticancer agents for this tumor
References
Publications (0)
Data not yet available
No reference posted for this study.