Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen.
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|ClinicalTrials.gov Identifier: NCT02033993|
Recruitment Status : Active, not recruiting
First Posted : January 13, 2014
Last Update Posted : February 1, 2018
The purpose of this study is to compare the effects on urothelial cancer of nab-paclitaxel compared to paclitaxel to treat this disease.
This research is being done because currently there is no effective treatment for urothelial cancer that has progressed after prior chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Cancer||Drug: Nab-Paclitaxel Drug: Paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||199 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advanced Urothelial Cancer Progressing on or After a Platinum Containing Regimen.|
|Actual Study Start Date :||January 27, 2014|
|Actual Primary Completion Date :||January 11, 2018|
|Estimated Study Completion Date :||September 2018|
Active Comparator: Arm 1
Nab-Paclitaxel - 260mg/m2: q21 days
Active Comparator: Arm 2
Paclitaxel - 175mg/m2: q21 days
- Progression-Free Survival [ Time Frame: 42 months ]PFS is defined as the time from randomization to the first observation of disease progression or death due to any cause.
- Overall Survival [ Time Frame: 42 months ]
- Clinical Benefit Rate [ Time Frame: 42 months ]ORR+SD > 12 weeks
- Time to Response and Response Duration [ Time Frame: 42 months ]
- Nature, severity and frequency of toxicities [ Time Frame: 42 monts ]Including neuropathy between the two arms
- Quality of Life [ Time Frame: 42 months ]
Quality of life will be assessed using the EORTC-C15-PAL questionnaire plus additional study specific questions.
Changes in quality of life scores while on treatment (compared to baseline scores) will be examined using descriptive analyses and inferential statistics. The primary test to compare treatment arms will be a Wei-lachin test for stochastic ordering, including all time points where QoL was measured. In addition, baseline scores between arms will be compared using a Wilcoxon rank sum test, and a pattern mixture model identifying drop-out patients as a special category will be performed to evaluate the effect of missing data.
- Cost and cost utility ratios between the two arms [ Time Frame: 42 months ]To determine the incremental costs and effectiveness and cost utility ratios for nab-paclitaxel versus paclitaxel
- Tissue Markers at diagnosis [ Time Frame: 42 months ]To correlate the expression of tissue markers (at diagnosis) with outcomes and response in an exploratory fashion.
- Genetic polymorphisms that may impact on response or toxicity [ Time Frame: 42 months ]To assess genetic polymorphisms that may impact on response or toxicity to the taxanes.
- Effect modification of clinico-demographic factors [ Time Frame: 42 months ]To assess the effect modification of and adjust for clinico-demographic factors captured in a health and demographic questionnaire with respect to the relationships between biomarkers, quality of life, health economics, disease outcomes, and treatment toxicities.
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): NCT02033993
Show 37 Study Locations
|Study Chair:||Srikala Sridhar||Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario Canada|