NCT00410904

AZD2171 and Pemetrexed Disodium in Treating Patients With Relapsed Non-Small Cell Lung Cancer

Phase 2 Study of AZD2171 (NSC 732208) in Combination With Pemetrexed in Relapsed Non-Small Cell Lung Cancer (NOS: 10029514)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving AZD2171 together with pemetrexed disodium works in treating patients with relapsed non-small cell lung cancer. AZD2171 and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. AZD2171 may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving AZD2171 together with pemetrexed disodium may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the response rate in patients with relapsed non-small cell lung cancer treated with AZD2171 and pemetrexed disodium. SECONDARY OBJECTIVES: I. Assess the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to prior bevacizumab treatment (yes vs no). Patients receive oral AZD2171 once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks\* in the absence of disease progression or unacceptable toxicity. \[Note: \* The first course is 4 weeks in duration; all subsequent courses are 3 weeks in duration.\] After completion of study treatment, patients are followed at 4 weeks and then periodically thereafter.

Conditions

• Recurrent Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	cediranib maleate
DRUG	pemetrexed disodium

Timeline

• Start date: 2006-10-01
• Primary completion: 2013-07-01
• Completion: 2014-03-01
• First posted: 2006-12-13
• Last updated: 2018-04-13
• Results posted: 2014-09-22

Locations

2 sites across 1 country: United States