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

NCT02564146 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2022-11-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • ClinAssess GmbH

    collaborator INDUSTRY

  • Celgene Corporation

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Frank Kullmann, Prof. Dr. · Kliniken Nordoberpfalz AG Klinikum Weiden Medizinische Kliniken I

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2022-03-31
Completion
2022-05-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02564146 on ClinicalTrials.gov