Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Amino Acids

Pemetrexed

Mitogens

Gefitinib

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Tyrosine

treatment of single pemetrexed with vitamin supplement until discontinued conditions are met

Pemetrexed (Alimta)

treatment of Gefitinib will be applied until discontinued conditions are met

Gefitinib (IRESSA)

This study is a prospective trial of Alimta (pemetrexed) versus IRESSA (gefitinib) among epidermal growth factor receptor wild-type Non-Small Cell Lung Cancer (NSCLC) patients in a 2nd line setting.

Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without Epidermal Growth Factor Receptor (EGFR) Mutations

Phase 2 Randomized, Controlled, Open-label Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without EGFR Mutations

Chinese Society of Lung Cancer

Director of Chinese Society of Lung Cancer/Chief of Lung Cancer Research Institute & Cancer Center/Vice President of Guangdong General hospital

Rare Diseases

Adenocarcinoma

Adenocarcinoma of Lung

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Adenocarcinoma

Erlotinib Hydrochloride

If EGFR mutation found then assigned to thyrosine kinase inhibitor (erlotinib)

If EGFR wild type found then assigned to chemotherapy (pemetrexed)

erlotinib (Tarceva)

pemetrexed (Alimta)

Wu-Chou Su, PHD

Hui-Shu Yang, Bachelor

Wu-Chou Su, PhD

Currently the investigators have two different classes of second-line treatment options in recurrent non-small Cell Lung Cancer (NSCLC). In chemotherapy, docetaxel and pemetrexed produced similar treatment efficacy outcomes, while pemetrexed had a better tolerability. In recent analysis of pemetrexed clinical studies, a strong treatment-by-histology interaction in overall survival and progression free survival that indicated better efficacy for non-squamous patients treated with pemetrexed. These data supports that pemetrexed could be a preferable chemotherapy drug especially in adenocarcinoma NSCLC patients.

On the other hand, EGFR TKI (gefitinib or erlotinib) both produced somewhat similar higher response rate (around 25%) in general Taiwan adenocarcinoma NSCLC patients, while the median overall survival time didn't longer than chemotherapy treated patients. A recent prospective study of gefitinib in chemonaive adenocarcinoma NSCLC patients showed that the objective response rate was lower to be only 1.1% among EGFR mutation negative patients.

Since typical EGFR gene mutations (i.e., the deletion of typically five amino acids at codons 746-750 (ELREA) in exon 19 and a leucine-to-arginine mutation at codon 858 (L858R)) are a good predictor for tumor response to tyrosine kinase inhibitor, this present study is to tailor the patient's treatment according to his/her EGFR gene mutation status. Receptor tyrosine kinase inhibitor (erlotinib in this study) will be the suggested second-line drug of recommendation for typical EGFR gene mutation patients, and chemotherapy (pemetrexed in this study) will be the suggested second-line drug of recommendation for EGFR wild type patients.

The aim of this study is to increase the overall tumor response rate to 40% from current treatment outcome (around 25%) by this tailored second line treatment. The further interests of this study include prospectively evaluate the predictivity of EGFR gene mutation to tumor response.

The primary objective of this study is to determine the overall tumor response rate of tailored second line treatment determined by typical EGFR gene mutation in patients with advanced lung adenocarcinoma.

Tailored Second Line Treatment by Epidermal Growth Factor Receptor (EGFR) Mutation in Patients With Advanced Lung Adenocarcinoma

Tailored Second Line Treatment by EGFR Mutation in Patients With Advanced Lung Adenocarcinoma

National Cheng-Kung University Hospital

Wu- Chou Su

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Nasopharyngeal Neoplasms

Recurrence

Nasopharyngeal Carcinoma

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Vitamin B 12

Hydroxocobalamin

Methylcobalamin

Vitamin B12

Cobalamin

Cyanocobalamin

500 mg/m2 in Cycle 1, every 3 weeks, with folic acid and vitamin B12 supplementation.

Li Zhang, Master

This is a pilot phase II study of locally advanced or metastatic nasopharyngeal carcinoma (NPC) with the single drug Alimta. The objective of this study is to assess efficacy and safety profiles of Alimta as 2nd line treatment for patients with advanced NPC.

Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy

Open-Label Single-Arm Phase 2 Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Had Prior Platinum Based Chemotherapy

Eli Lilly and Company

Sun Yat-sen University

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Pemetrexed Versus Gefitinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy Without Epidermal Growth Factor Receptor (EGFR) Mutations	NCT00891579	Non Small Cell ...	Pemetrexed (Ali... Gefitinib (IRES...	18 Years - 80 Years	Chinese Society of Lung Cancer
Tailored Second Line Treatment by Epidermal Growth Factor Receptor (EGFR) Mutation in Patients With Advanced Lung Adenocarcinoma	NCT00903292	Non-Small Cell ...	erlotinib (Tarc... pemetrexed (Ali...	20 Years - 80 Years	National Cheng-Kung University Hospital
Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy	NCT00630149	Nasopharyngeal ...	Pemetrexed (Ali...	18 Years -	Sun Yat-sen University
Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy	NCT00630149	Nasopharyngeal ...	Pemetrexed (Ali...	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for pemetrexed (alimta)