NL-OMON30374
Completed
Phase 2
A parallel phase II study of Tarceva®(Erlotinib) in patients with advanced non-small cell lung cancer (Stage IIIB/IV) not pre-treated by chemotherapy including dose escalation to toxicity in current and former smokers - Tarceva in NSCLC never smokers vs. smokers
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 8
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •\- Patients with histological documented, locally advanced or recurrent (stage IIIB and not amenable for combined modality treatment) or metastatic (Stage IV) NSCLC who have not received prior chemotherapy for advanced disease.
- •\- Formalin\-fixed, paraffin\-embedded primary diagnosis lung tumour tissue samples (tissue blocks are preferred over slides) representative of the tumour and collected prior to starting erlotinib therapy will be provided to the co\-ordinating investigator within 3 weeks of the patient starting erlotinib therapy. This Is A Mandatory Requirement For Study Entry
- •\- No prior chemotherapy for advanced disease. Previous adjuvant treatment is permitted if patient relapsed \* 1 year after the end of the chemotherapy.
- •\- Measurable disease according to RECIST.
- •\- Age 18 or greater.
- •\- Able to comply with study and follow\-up procedures.
- •\- Patients must be able to take oral medication.
- •\- Written (signed) Informed Consent (WIC) to participate in the study.
- •\- ECOG performance status of 0 \- 2\.
- •\- Life expectancy of at least 12 weeks.
Exclusion Criteria
- •1\. Any unstable systemic disease including:
- •\- active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol treatment,
- •\- uncontrolled hypertension,
- •\- unstable angina,
- •\- severe heart disease (NYHA stages III and IV heart failure, unstable angina, uncontrolled arrhythmia in particular)
- •congestive heart failure,
- •\- history of myocardial infarction within the previous year,
- •\- serious cardiac arrhythmia requiring medication,
- •\- hepatic, renal or metabolic disease,
- •2\. Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
Investigators
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