Oxaliplatin and Pemetrexed Disodium in Treating Patients With Refractory Hormone-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01338792|
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : December 11, 2013
Last Update Posted : March 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hormone-resistant Prostate Cancer Recurrent Prostate Cancer||Drug: oxaliplatin Drug: pemetrexed disodium Other: questionnaire administration Other: laboratory biomarker analysis Genetic: reverse transcriptase-polymerase chain reaction Genetic: polymorphism analysis||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Oxaliplatin and Pemetrexed in Hormone Refractory Prostate Cancer|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2012|
Experimental: Treatment (chemotherapy and enzyme inhibitor)
Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Drug: pemetrexed disodium
Other: questionnaire administration
Other: laboratory biomarker analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other Name: RT-PCR
Genetic: polymorphism analysis
- Best Overall Response [ Time Frame: RECIST evaluation: Baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. PSA evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year ]For patients with measurable disease, the RECIST 1.0 criteria was used to determine response. Complete Response = disappearance of all target lesions, Partial Response = greater or equal to 30% decrease in sum of longest diameter or target lesions, Stable Disease = <30% decrease or <20% increase, Progressive Disease = greater or equal to 20% increase in longest diameter of target lesions. For patients who do not have measurable disease by RECIST, the response was based on PSA response defined by Prostate Cancer Working Group criteria (1999) as 50% reduction in PSA confirmed on a second measurement at least 4 weeks later.
- Time to Disease Progression and Overall Survival [ Time Frame: Baseline, after every 2 courses, and then every 6 months after off-study (RECIST) until progression; or baseline, day 1 of each course, at the final evaluation, and then every 6 months after off-study (PSA) until progression ]Progression-free survival was defined as the time from the first infusion of study treatment to the date of radiographic disease progression according to RECIST 1.0, or until two consecutive PSA rises occurred with an absolute increase of 5 ng/mL and a 50% relative increase over baseline. For patients without documented disease progression, the date of death or last follow-up without disease progression was used.
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Baseline, days 1 and 7 of each course, and at last evaluation, up to 1 year ]Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
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): NCT01338792
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Jacek Pinski||University of Southern California|