NCT02564146

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Metastatic Pancreatic Cancer
• Adenocarcinoma of the Pancreas

Interventions

Type	Name	Description
DRUG	nab-paclitaxel and gemcitabine	Induction treatment: 3 cycles nab-paclitaxel and gemcitabine 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle. Continouous treatment after randomization: Continuing application of nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity. Duration of each cycle is 28 days nab-paclitaxel 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.
DRUG	gemcitabine mono and nab-paclitaxel and gemcitabine	Induction treatment: 3 cycles nab-paclitaxel and gemcitabine 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle. Continouous treatment after randomization: Alternating application of gemcitabine monotherapy and nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity, starting with a treatment cycle of gemcitabine monotherapy. Duration of each cycle irrespective of treatment cycle with gemcitabine monotherapy or treatment with nab-paclitaxel/gemcitabine is 28 days. Gemcitabine monotherapy treatment cycle: Gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle. Nab-paclitaxel and gemcitabine treatment cycle: Nab-paclitaxel 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.

Timeline

• Start date: 2016-12-01
• Primary completion: 2022-03-01
• Completion: 2022-05-01
• First posted: 2015-09-30
• Last updated: 2022-11-22

Locations

1 site across 1 country: Germany