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

Gemcitabine

Paclitaxel

Pemetrexed

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Gemcitabine 1,250 mg/sqm days 1 and 8 + Alimta 500 mg/sqm day 8, every 3 weeks

Paclitaxel 120 mg/sqm days 1 and 8 + Gemcitabine 1,000 mg/sqm days 1 and 8, every 3 weeks

gemcitabine 1,250 mg/sqm days 1\&8 + pemetrexed 500 mg/sqm day 8 paclitaxel 120 mg/sqm + gemcitabine 1,000 mg/sqm days 1\&8

gemcitabine plus pemetrexed, paclitaxel plus gemcitabine

Pasquale Comella, MD

The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG regimen) in terms of toxicity and QoL

Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to receive: (a)PG regimen: paclitaxel 120 mg/sqm followed by gemcitabine 1,000 mg/sqm i.v. on days 1 \& 8 q 3 weeks; (b)GA regimen: gemcitabine 1,250 mg/sqm i.v. on day 1 (plus folinic acid 350 μg daily orally and vitamin B12 1,000 μg i.m. q 9 weeks), pemetrexed (Alimta®) 500 mg/sqm i.v. on day 8 followed by gemcitabine 1,250 mg/sqm, q 3 weeks.

Alimta and Gemcitabine in Non-Small Cell Lung Cancer

A Phase II Randomized Trial Assessing the Combination of Gemcitabine and Pemetrexed in the First Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Southern Italy Cooperative Oncology Group

Pasquale Comella MD

Cisplatin

Panitumumab

Antineoplastic Agents, Immunological

Panitumumab 9 mg/kg BW will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

In case of CR, PR or SD status at the end of the combination treatment, a panitumumab single drug treatment, consisting of 9 mg/kg BW administered every 3 weeks, will be performed until detection of disease progression.

Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Wolfgang Schütte, MD

The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with pemetrexed and cisplatin) in relation to the standard combination in patients with a KRAS wild-type stage IIIB or IV primary nonsquamous non-small cell lung cancer. It is expected that the progression free survival rate at 6 months is improved by the targeted regimen.

Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Non-small Cell Lung Cancer

CHAMP - An Open-label, Randomised, Multicentre, Phase II Clinical Study of Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Stage IIIB or IV Primary Nonsquamous Non-small Cell Lung Cancer, With Particular Regard to the KRAS Status

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

WiSP Wissenschaftlicher Service Pharma GmbH

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alimta and Gemcitabine in Non-Small Cell Lung Cancer	NCT00434135	Non-Small Cell ... Stage IIIB or I...	gemcitabine plu...	18 Years - 85 Years	Southern Italy Cooperative Oncology Group
Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Non-small Cell Lung Cancer	NCT01088620	Carcinoma, Non-...	Panitumumab Pemetrexed Cisplatin	18 Years -	WiSP Wissenschaftlicher Service Pharma GmbH
Alimta and Gemcitabine in Non-Small Cell Lung Cancer	NCT00434135	Non-Small Cell ... Stage IIIB or I...	gemcitabine plu...	18 Years - 85 Years	Southern Italy Cooperative Oncology Group

Spots Global Cancer Trial Database for stage iiib or iv