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
- Conditions
- 1. non-small cell lung cancersquamous cell lung malignancy10038666
- Registration Number
- NL-OMON30374
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
- 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.
- At least 4 weeks since any prior surgery or radiotherapy. Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy.
- Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3; Haemoglobin * 9.0g/dl.
- Serum bilirubin within upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) < 2.5 x ULN (or * 5 x ULN in case of liver metastases).
- Serum creatinine * 1.5 ULN or creatinine clearance * 60 ml/min.
- For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy. Patients with reproductive potential must use effective contraception.
- Patients that either can be classified as never smokers or as current/former smokers according to the definitions in section 3.1 (note that all other smokers (e.g. cigar, pipe) will be excluded from study participation).
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).
3. Patients are excluded if they have clinical evidence of brain metastasis, or have brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months will also cause patients to be excluded.
4. Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the study medication.
5. Previous treatment with any therapy which acts on the EGFR axis.
6. Patients unable to take oral medication, requiring intravenous alimentation, who have mal-absorption syndrome or any other condition affecting gastrointestinal absorption, or who have active peptic ulcer disease.
7. Nursing and/or pregnant women.
8. Any inflammatory changes of the surface of the eye.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variable is the non progression rate (NPR). The NPR is<br /><br>defined as the proportion of patients without progression (based on RECIST<br /><br>criteria) at 8 weeks after start of treatment, i.e. all patients with a<br /><br>response rating of Complete Response (CR), Partial Response (PR), or Stable<br /><br>Disease (SD) according to RECIST that is documented for at least 8 weeks from<br /><br>baseline. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy parameters include overall response rate using RECIST<br /><br>criteria, response duration, time to progression, progression-free survival and<br /><br>overall survival.</p><br>