Status:
UNKNOWN
Study of Blood and Tissue Samples in Predicting Response to Second-Line Therapy Using Erlotinib Hydrochloride or Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Istituto Scientifico H. San Raffaele
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Studying the proteins expressed in samples of blood and tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patient...
Detailed Description
OBJECTIVES: * To evaluate the predictive value of proteomic profiling on the effect of second-line therapy with erlotinib hydrochloride vs standard chemotherapy (pemetrexed disodium or docetaxel) in ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Advanced NSCLC (stage IIIB or IV)
- Measurable disease
- Underwent previous treatment with 1 non-tyrosine kinase inhibitor as first-line therapy for advanced NSCLC
- No clinical evidence of uncontrolled brain metastases
- PATIENT CHARACTERISTICS:
- Caucasian
- ECOG performance status 0-2
- Absolute granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 2.5 times ULN in patients with known liver metastases)
- ALT or AST ≤ 3 times ULN (≤ 5 times ULN in patients with known liver metastases)
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Able to comply with planned study procedures
- No multiple severe diseases that can compromise safety (cardiac and renal failure, peripheral neuropathy)
- No other malignancy (except for basal cell skin carcinoma) or pre-neoplastic condition requiring chemotherapeutic treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior surgery or radiotherapy
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00989690
Start Date
February 1 2008
Last Update
August 12 2013
Active Locations (1)
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1
Istituto Scientifico H. San Raffaele
Milan, Italy, 20132