NCT00356525

Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor

Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to help answer: * Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last * Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer

Conditions

• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	pemetrexed	500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
DRUG	gemcitabine	1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
DRUG	carboplatin	area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
DRUG	Pemetrexed	500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-06-01
• Completion: 2009-04-01
• First posted: 2006-07-26
• Last updated: 2010-08-17
• Results posted: 2009-07-29

Locations

17 sites across 3 countries: United States, Brazil, India