Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00391274|
Recruitment Status : Completed
First Posted : October 23, 2006
Results First Posted : March 30, 2010
Last Update Posted : April 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: pemetrexed Drug: docetaxel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||June 2010|
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment
|Active Comparator: Docetaxel||
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment
- Overall Survival [ Time Frame: baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment) ]Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.
- Overall Tumor Response [ Time Frame: baseline to measured tumor response (up to 24 months after study enrollment) ]Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria.
- Progression-Free Survival (PFS) [ Time Frame: baseline to measured progressive disease (up to 24 months after study enrollment) ]Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.
- Duration of Response [ Time Frame: time of response to progressive disease (up to 24 months) ]Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as "Number of Patients with Disease Progression".
- Pharmacology Toxicity [ Time Frame: first dose of study drug up to 24 months ]Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.
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): NCT00391274
|Beijing, China, 101149|
|Guang Zhou, China, 510080|
|Hang Zhou, China, 310022|
|Nan Jing, China, 210002|
|Shanghai, China, 200433|
|Tianjin, China, 300060|
|Wu Han, China, 430030|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|