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
NCT ID: NCT00989690
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
275 participants
INTERVENTIONAL
2008-02-29
Brief Summary
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PURPOSE: This randomized phase III trial is studying 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.
Detailed Description
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* 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 patients with advanced non-small cell lung cancer.
* To assess the role of other known tissue-based predictive markers (e.g., EGFR-gene copy number, EGFR-protein expression, pAkt, pMAPK, EGFR mutations, EMT markers, and k-Ras mutation).
OUTLINE: This is a multicenter study. Patients are stratified according to smoking status, performance status, proteomic profile, and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive standard chemotherapy with pemetrexed disodium, docetaxel, or another standard drug.
* Arm II: Patients receive standard non-chemotherapy treatment with erlotinib hydrochloride.
Serum is collected after failure of first-line therapy for proteomic analysis by matrix-associated laser desorption/ionization-time of flight. Tissue and blood samples are collected periodically for analysis including EGFR based on IHC and FISH, EGFR and k-Ras mutations, pAkt, pMAPK by IHC, and EMT markers based on IHC and breath condensate protein profile.
After completion of study treatment, patients are followed every 2 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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docetaxel
erlotinib hydrochloride
pemetrexed disodium
fluorescence in situ hybridization
mutation analysis
proteomic profiling
immunohistochemistry staining method
laboratory biomarker analysis
matrix-assisted laser desorption/ionization time of flight mass spectrometry
breath test
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Istituto Scientifico H. San Raffaele
OTHER
Principal Investigators
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Vanesa Gregor, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Scientifico H. San Raffaele
Locations
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Istituto Scientifico H. San Raffaele
Milan, , Italy
Countries
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Facility Contacts
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Vanesa Gregor, MD
Role: primary
References
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Gregorc V, Novello S, Lazzari C, Barni S, Aieta M, Mencoboni M, Grossi F, De Pas T, de Marinis F, Bearz A, Floriani I, Torri V, Bulotta A, Cattaneo A, Grigorieva J, Tsypin M, Roder J, Doglioni C, Levra MG, Petrelli F, Foti S, Vigano M, Bachi A, Roder H. Predictive value of a proteomic signature in patients with non-small-cell lung cancer treated with second-line erlotinib or chemotherapy (PROSE): a biomarker-stratified, randomised phase 3 trial. Lancet Oncol. 2014 Jun;15(7):713-21. doi: 10.1016/S1470-2045(14)70162-7. Epub 2014 May 13.
Other Identifiers
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CDR0000652115
Identifier Type: REGISTRY
Identifier Source: secondary_id
2007-006299-13
Identifier Type: -
Identifier Source: secondary_id
EU-20975
Identifier Type: -
Identifier Source: secondary_id
SRSI-HSRL-02-2007
Identifier Type: -
Identifier Source: org_study_id