Status:
TERMINATED
Erlotinib as First-line Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) for Patients Unfit for Chemotherapy
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A phase II study of Tarceva (Erlotinib) and predictive markers as first-line treatment of advanced non-small cell lung cancer for patients unfit for chemotherapy (NSCLC) Clinical Phase II Stage IIIB o...
Eligibility Criteria
Inclusion
- Histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.
- Chemo-naïve patients.
- Patients who are in the investigator's opinion not medically suitable for chemotherapy.
- Measurable disease according to the RECIST criteria.
- ECOG performance status of 0 - 3.
- Life expectancy of at least 12 weeks.
- Patients must be able to take oral medication.
- Serum calcium within normal ranges
- ≥ 4 weeks since prior surgery or radiation therapy
- For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting therapy and must use effective contraception
- 18 years of age or older
- Written (signed) Informed Consent to participate in the study
Exclusion
- Prior systemic antitumor therapy
- Any unstable systemic disease which according to the investigator contraindicates the use of the study drug render the subject at high risk from treatment complications (including active infection, unstable angina, myocardial infarction within the previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2 upper limit of normal (ULN) or AST and/or ALT ≥ 2 x ULN (or ≥ 5 x ULN if clearly attributable to liver metastasis), renal disease with acute renal failure or serum creatinine ≥ 5 x ULN.
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Nursing mothers or pregnant woman.
- Hypersensitivity to Tarceva or co-formulants.
- Patients with brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation.
- Patients with brain metastasis or spinal cord compression that not are in a stable condition despite treatment with steroids.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00452075
Start Date
March 1 2007
End Date
August 1 2010
Last Update
December 11 2014
Active Locations (3)
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1
Department of Oncology, Århus University Hospital
Aarhus, Denmark, 8000
2
Department of Oncology, Rigshospitalet
Copenhagen, Denmark, 2100
3
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000