Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Diseases

Respiratory Tract Diseases

Thoracic Neoplasms

Respiratory Tract Neoplasms

Bronchial Neoplasms

Carcinoma, Bronchogenic

Bronchial Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Vinorelbine

Carboplatin

Pemetrexed

Docetaxel

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

At discretion of the treating phisician. Common chemotherapic regimens include:

Gemcitabine at 1000 or 1250 mg/m2 IV (in the vein) on day 1 and 8 of each 21 day cycle.

Carboplatin at an AUC of 5 IV on day 1 of each 21 day cycle plus Gemcitabine at 1000 mg/m2 IV on Day 1 and 8 of each 21 day cycle.

Carboplatin at an AUC of 5 IV on Day 1 of each 21 day cycle plus Pemetrexed 500mg/m2 on day 1 IV on Day 1 of each 21 day cycle.

Vinorelbine 30 mg/m2 IV on day 1 and day 8 every 3 of each 21 day cycle.

Number of Cycles: to a maximum of 6 cycles until progression or unacceptable toxicity.

Treatment prescriptions will be based on gene analysis:

* Carboplatin at an AUC of 6 IV (in the vein) on day 1 of each 21 day cycle.
* Gemcitabine at 1000 mg/m2 IV on day 1 and 8 of each 21 day cycle.
* Carboplatin at an AUC of 5 IV on day 1 of each 21 day cycle plus Gemcitabine at 1000 mg/m2 IV on Day 1 of each 21 day cycle.
* Carboplatin at an AUC of 5 IV on Day 1 of each 21 day cycle plus Pemetrexed at 500 mg/m2 IV on Day 1 of each 21 day cycle.
* Pemetrexed 500mg/m2 IV on Day 1 of each 21 day cycle.
* Docetaxel 75 mg/m2 IV on Day 1 of each 21 day cycle. Or Vinorelbine 30 mg/m2 IV on day 1 and day 8 of each 21 day cycle.

Number of Cycles: to a maximum of 6 cycles until progression or unacceptable toxicity.

Silvia Novello, MD,PhD

Marco Angelo Burgio, MD

Alessandra Bearz, MD

Alessandro Gamboni, MD

Gianni Michele Turolla, MD

Maximilian Papi, MD

Silvia Novello, MD, PhD

Domenico Galetta, MD

Giuseppe Banna, MD

Ida Colantonio, MD

Fabiana Cecere, MD

Francesco Grossi, MD

Carlotta Defferrari, MD

Gabriella Farina, MD

Vanesa Gregorc

Paolo Bidoli, MD

Adolfo Favaretto, MD

Lucio Crinò, MD

Claudio Dazzi, MD

Corrado Boni, MD

Francesco Cognetti, MD

oLGA Martelli, MD

Enrico Cortesi, MD

Lorenzo Cordero, MD

Giuseppe Valmadre, MD

Orazio Caffo, MD

Alessandro Follador, MD

Gianpaolo Tortora, MD

Giorgio Vittorio Scagliotti, MD, PhD

Tiziana Vavalà, MD

This is a randomized phase III trial that will randomize elderly patients(70 years of age and older) who are not considered eligible for standard doublet or triplet regimens. In a 2:1 fashion, patients will be randomized to the customization arm or the standard arm, respectively. This trial will be offered to patients who are previously untreated for stage IV NSCLC.

The primary objective is to evaluate if chemotherapy selection based on histology and tumoral molecular determinants ERCC1, RRM1 and TS (arm A, the experimental arm) results in superior outcome in elderly patients with untreated, advanced NSCLC compared to standard of care treatments (arm B, the standard arm).

The study population will consist of patients with histologically or cytologically proven stage IV NSCLC, who have not been previously treated with chemotherapy for stage IV and are either elderly (70 years of age and older). Patients must fulfill all the inclusion/exclusion criteria to be eligible.

Tissue will be obtained, and gene expression analysis will be performed at the University of Turin. The tissue sample used for this analysis will be obtained from the biopsy procedure performed as standard of care procedures during the patient's diagnosis and staging. Patients will be randomized to either Arm A: Experimental or Arm B: Standard of Care in a 2:1 fashion.

Tissue will be obtained for gene analysis for ALL patients. However, ONLY patients randomized to Arm A will receive the genetic analysis results. Genetic results will not be disclosed to the registering center for those patients randomized to Arm B: Standard of Care.

For patients randomized to Arm A: Experimental arm, the chemotherapy treatment prescription will be based on the gene analysis according to the protocol. For patients randomized to Arm B: Standard of Care arm, the chemotherapy treatment will be at the discretion of the care provider.

The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial

Randomized Phase III Multicenter Trial of Customized Chemotherapy Versus Standard of Care for1st Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer

adverse events and serious adverse events as a measure of safety and tolerability

Rate of successfully conducted gene expression analysis in patients that have signed the informed consent document

primary endpoint is OS (determined from the date of randomization).Assuming an exponential survival distribution for both treatment arms and a median survival time of 8 months in the control arm we anticipate to detect an improvement of three months in OS.

PFS at 6 months (determined from the date of randomization). The anticipated 6-month PFS in arm B is approximately 25% and the goal in the experimental arm is to achieve a 32% improvement to 33%.

University of Turin, Italy

Principal Investigator

Spots Global Cancer Trial Database for stage iv, nsclc