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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00989690

First received: October 2, 2009

Last updated: August 9, 2013

Last verified: October 2009

History of Changes

Purpose

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 patients will respond to treatment.

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.

Condition	Intervention	Phase
Lung Cancer	Drug: docetaxel Drug: erlotinib hydrochloride Drug: pemetrexed disodium Genetic: fluorescence in situ hybridization Genetic: mutation analysis Genetic: proteomic profiling Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry Procedure: breath test	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib Versus Chemotherapy in Patients With Inoperable Non Small Cell Lung Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival

Secondary Outcome Measures:

Progression-free survival
Overall response rate according to RECIST criteria


Estimated Enrollment:	275
Study Start Date:	February 2008

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 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989690

Locations


Italy
Istituto Scientifico H. San Raffaele	Recruiting
Milan, Italy, 20132
Contact: Vanesa Gregor, MD 39-02-2643-7623

Sponsors and Collaborators

Istituto Scientifico H. San Raffaele

Investigators


Principal Investigator:	Vanesa Gregor, MD	Istituto Scientifico H. San Raffaele

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Viganò 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.


ClinicalTrials.gov Identifier:	NCT00989690 History of Changes
Other Study ID Numbers:	SRSI-HSRL-02-2007 CDR0000652115 ( Registry Identifier: PDQ (Physician Data Query) ) 2007-006299-13 EU-20975
Study First Received:	October 2, 2009
Last Updated:	August 9, 2013

Keywords provided by National Cancer Institute (NCI):


recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic	Bronchial Neoplasms Erlotinib Hydrochloride Pemetrexed Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 21, 2017

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