Biomarkers Impact On the response to Treatment with Erlotinib

Phase 1

Conditions: on-small cell lung cancer

Registration Number: EUCTR2009-017063-42-RO

Lead Sponsor: Roche Romania SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Written informed consent (informed consent document to be approved by the National Ethics Committee and consent obtained prior to any study-specific procedure) for biomarkers testing and drug administration
2.Able to comply with the protocol
3.Age = 18 years
4.Histological documented adenocarcinoma, locally advanced - stage IIIb, metastatic - stage IV or recurrent non-squamous NSCLC.
5.Eastern Cooperative Oncology Group PS status 0-1
6.Life expectancy = 12 weeks
7.Patients must have evidence of disease with at least one measurable disease evaluate on RECIST criteria
8.Adequate haematological function:
a.Absolute neutrophil count (ANC) =1.5 x 109/L AND
b.Platelet count =100 x 109/L AND
c.Haemoglobin =9 g/dL (may be transfused to maintain or exceed this level)
9.Adequate liver function:
d.Total bilirubin <1.5 x upper limit of normal (ULN) AND
e.Asparagine aminotransferase (AST), alanine aminotransferase (ALT) <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
10.Normal Serum calcium
11.Female and male patients with reproductive potential must use effective contraception.
12.If female, should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to enrolment into the study. If a serum pregnancy test is not performed within 7 days prior to the first dose of erlotinib, a confirmatory urine test (within 72 hours prior to the first dose of erlotinib) is required.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Inability or unwillingness to provide informed consent
2.Squamous non-small cell or small cell tumors or absence of histological report
3.Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
4.Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzumab).
5.Prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor) for the treatment of the patient’s current stage of disease (stage IIIB with pleural or pericardial effusion, stage IV or recurrent disease). NOTE: prior surgery and irradiation is permitted provided that the criteria outlined in the protocol for both treatments are met.
6.Radical radiotherapy with curative intent within 28 days prior to enrolment. Palliative radiotherapy for relief of bone pain not involving the thoracic region is allowed prior to enrolment.
7.Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
8.Any active, non-controlled systemic disease (including infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
9.Clinically significant (i.e. active) cardiovascular disease for example CVA (=6 months before enrolment), myocardial infarction (=6 months before enrolment), unstable angina, congestive heart failure NYHA Class =II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
10.Evidence of ongoing or active infection, any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
11.History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
12.Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent
13.Serum creatinine > 1.5 ULN and/or creatinine clearance < 60 mL/min.
14.Patients are excluded if they have brain metastasis or spinal cord compression that 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.
15.Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception (oral contraceptives in case not contraindicated for use with concomitant treatment, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of erlotinib. Men who do not agree to use effective contraception during the study and for a period of 90 days following the last administration of erlotinib.
16.Known hypersensitivity to erlotinib or any of its excipients, and any of the chemotherapies
17.Patients who cannot take oral medication, who require intra