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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Scientifico H. San Raffaele
• Treatments: Docetaxel; Erlotinib Hydrochloride; Pemetrexed

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