Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer (NAPGAP)
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|ClinicalTrials.gov Identifier: NCT02135822|
Recruitment Status : Unknown
Verified May 2014 by Liu, Rong, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : May 12, 2014
Last Update Posted : May 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Pancreatic Cancer||Drug: nanoparticle albumin-bound paclitaxel Drug: gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Chinese Patients With Advanced Pancreatic Cancer|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: nanoparticle albumin-bound paclitaxel, gemcitabine
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8, in combination with gemcitabine which is given at 1000 mg/m2, on day 1 and 8, each 21-day cycle. Number of cycle: 6 cycles.
Drug: nanoparticle albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.
Gemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.
Other Name: Gemzar
- Overall response rate [ Time Frame: Measure at every 6 weeks (every 2 cycles) up to 18 weeks ]Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
- Progression-free survival [ Time Frame: up to 15 months ]Measurement of time from study treatment to disease progression or death.
- Overall survival [ Time Frame: up to 2 years ]Measurement of time from study treatment to patient's death or lost to follow-up.
- Disease control rate [ Time Frame: Measure every 6 weeks (every 2 cycles) up to 18 weeks ]The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).
- Safety and tolerability [ Time Frame: up to 18 month ]Percentage of patients who experience adverse events during this study.
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): NCT02135822
|Contact: Rong Liufirstname.lastname@example.org|
|Contact: Fei Wangemail@example.com|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Principal Investigator: Rong Liu|
|Principal Investigator:||Rong Liu||Chinese PLA General Hospital|