Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
|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: NCT00198133|
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Thymoma Thymic Carcinoma||Drug: Premetrexed (Alimta)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma|
|Study Start Date :||January 2005|
|Primary Completion Date :||December 2006|
|Study Completion Date :||May 2012|
Pemetrexed infusion once every 21 days (one cycle).
Drug: Premetrexed (Alimta)
Pemetrexed will be 500 mg/m2 IV every 3 weeks
- Objective Response Rate (Complete and Partial Response) [ Time Frame: Up to 3 years ]The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.
- Duration of Remission [ Time Frame: Time from the date of remission until progression or death, assessed up to 3 years ]Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.
- Grade 3/4 Treatment Related Adverse Events [ Time Frame: Up to 3 years ]To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely).
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): NCT00198133
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Patrick Loehrer, M.D.||Indiana University|