AZD2171 and Pemetrexed Disodium in Treating Patients With Relapsed Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00410904|
Recruitment Status : Completed
First Posted : December 13, 2006
Results First Posted : September 22, 2014
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Non-small Cell Lung Cancer||Drug: cediranib maleate Drug: pemetrexed disodium||Phase 2|
I. Evaluate the response rate in patients with relapsed non-small cell lung cancer treated with AZD2171 and pemetrexed disodium.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of AZD2171 (NSC 732208) in Combination With Pemetrexed in Relapsed Non-Small Cell Lung Cancer (NOS: 10029514)|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||March 2014|
Experimental: Arm I
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.
Drug: cediranib maleate
Drug: pemetrexed disodium
- Response Rate (Complete and Partial) 2 Separate Cohorts of Relapsed NSCLC Cohort A: Pts Who Have Received Prior Chemo w/o Ever Having Received Bevacizumab. Cohort B: Pts Who Have Received Prior Bevacizumab. [ Time Frame: Up to 4 years ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0) for target lesions and assessed by MRI or CT:
Complete Response (CR): Disappearance of all target lesions
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Overall Response (OR) = CR + PR, the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started)
- Progression-free Survival [ Time Frame: The duration of time from start of treatment to time of progression, assessed up to 4 years ]Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Overall Survival [ Time Frame: The time from start of treatment to time of death, assessed up to 4 years ]Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410904
|United States, Maryland|
|University of Maryland/Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|United States, Michigan|
|Wayne State University/Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Shirish Gadgeel||Barbara Ann Karmanos Cancer Institute|