Pancreatic Cancer Research

Clinical trialPhase 2Completed

First-line Treatment of Metastatic Pancreatic Cancer With Nab-paclitaxel and Gemcitabine

Induction Treatment With Nab-paclitaxel/Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer Followed by Either Alternating Application of Gemcitabine Monotherapy and Nab-paclitaxel/Gemcitabine or Continuing Application of Nab-paclitaxel/Gemcitabine: A Randomized Phase II Study

Outcome
Finished, no results posted
Phase
Phase 2
Status
Completed
Study type
Interventional
Start
December 2016
Expected end
May 2022
Enrollment
325 participants
Sites
1
Primary outcomes
Overall survival (OS)
Sponsor
Other
Results posted
No
Last update
22 November 2022

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Brief summary public domain (ClinicalTrials.gov)

ALPACA is an interventional, multicentre, open-label, randomized active-controlled phase II trial with two arms. To estimate the treatment effect on overall survival, feasibility, efficacy and safety of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine cycles in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles of induction therapy with standard nab-paclitaxel/gemcitabine.

Detailed description public domain (ClinicalTrials.gov)

ALPACA is an interventional, multicentre, open-label, randomized active-controlled phase II trial with two arms. To estimate the treatment effect on overall survival, feasibility, efficacy and safety of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine cycles in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles of induction therapy with standard nab-paclitaxel/gemcitabine.