Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC) (LAPACT)
|Pancreatic Neoplasms||Drug: nab-Paclitaxel Drug: Gemcitabine Drug: Chemoradiation Drug: Capecitabine Procedure: Surgery||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||nab1-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).|
- Time to Treatment Failure [ Time Frame: up to 1 year from the time the last patient first treatment ]Time after the first dose of study therapy to treatment failure
- Disease Control Rate [ Time Frame: up to 6 months from last patient first treatment ]the combined incidence of complete response, partial response and stable disease measured at the End of Treatment visit
- Overall Response Rate [ Time Frame: up to 6 months from last patient first treatment ]the combined incidence of CR and PR
- Progression-free Survival [ Time Frame: up to 1 year from last patient last treatment ]the time after the first dose of study therapy to disease progression or death (by any cause)"
- Overall Survival [ Time Frame: up to last patient last visit ]the time after the first dose of study therapy to death by any cause
- Composite Health-related Quality of Life [ Time Frame: up to last patient last treatment ]Differences in outcomes from baseline, during treatment, and after treatment for the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQs), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ-C30) and Quality of Life Questionnaires (QLQ-PAN26).
- Number of Adverse Events [ Time Frame: up to 28 days from last patient last visit ]After signing Informed Consent Form (ICF) and until 28 days after the last dose of Investigational Product (IP) or 28-day Follow up Visit, whichever occurs later. Not during survival unless it is a suspected SAE.
|Study Start Date:||April 2015|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Experimental: nab-Paclitaxel plus Gemcitabine
nab-Paclitaxel 125 mg/m2 intravenous (IV) infusion over approximately 30 to 45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle Subjects who complete 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator will then determine the best option for the subject.
Other Name: AbraxaneDrug: Gemcitabine
Other Name: GemzarDrug: Chemoradiation Drug: Capecitabine Procedure: Surgery
This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. All subjects will be treated with nab-paclitaxel plus gemcitabine for 6 cycles followed by an Investigator's Choice of continuation of treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery.
Safety assessments by laboratory testing and physical exams will be conducted through-out the study.
Efficacy assessments by physical exam will be preformed through-out the study and tumor imaging will be conducted approximately every 2 months.
Subjects will be considered active study participants from enrollment up to, but not including, survival follow-up period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02301143
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|Study Director:||Teng Jin Ong, MD||Celgene|