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

  • Clinicaltrials.gov identifier

    NCT02564146

  • Recruitment Status

    Recruiting

  • First Posted

    September 30, 2015

  • Last update posted

    April 29, 2021

Study Description

Brief 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.

  • Condition or Disease:Metastatic Pancreatic Cancer
    Adenocarcinoma of the Pancreas
  • Intervention/Treatment: Drug: nab-paclitaxel and gemcitabine
    Drug: gemcitabine mono and nab-paclitaxel and gemcitabine
  • Phase: Phase 2

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 325 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 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
  • Study Start Date: December 2016
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2022

Arms and interventions

Arm Intervention/treatment
Experimental: gemcitabine monotherapy and nab-paclitaxel and gemcitabine (B)
Induction treatment: 3 cycles nab-paclitaxel and gemcitabine Continuous treatment after randomization: alternating application of gemcitabine monotherapy and nab-paclitaxel and gemcitabine treatment cycles
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.
Active Comparator: nab-paclitaxel and gemcitabine (A)
Induction treatment: 3 cycles nab-paclitaxel and gemcitabine Continuous treatment after randomization: Continuing application of nab-paclitaxel and gemcitabine treatment cycles
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.

Outcome Measures

  • Primary Outcome Measures: 1. Overall survival (OS) [ Time Frame: After randomization until date of death or end of study wichever comes first. Assessed for up to 38.5 month ]
    To estimate the treatment effect of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine treatment cycles in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles of induction therapy with standard nab-paclitaxel/gemcitabine.
  • Secondary Outcome Measures: 1. Overall survival (OS) [ Time Frame: 3.5 month ]
    During induction phase.
  • 2. Overall survival (OS) [ Time Frame: 42 month ]
    Determined from first application of induction treatment.
  • 3. Progression-free survival (PFS) [ Time Frame: 3.5 month ]
    During induction phase.
  • 4. Progression-free survival (PFS) [ Time Frame: Assessed for up to 38.5 month ]
    As time from randomization to objective tumor progression or death from any cause.
  • 5. Progression-free survival (PFS) [ Time Frame: Assessed for up to 42 month ]
    As time from randomization to objective tumor progression or death from any cause.
  • 6. Overall response rate (ORR) [ Time Frame: Assessed for up to 42 month ]
    According to RECISTv1.1 determined from first application of induction treatment.
  • 7. Overall response rate (ORR) [ Time Frame: Assessed for up to 3.5 month ]
    During induction phase.
  • 8. Disease control rate (DCR) [ Time Frame: Assessed for up to 42 month ]
    According to RECISTv1.1 determined from first application of induction treatment.
  • 9. Disease control rate (DCR) [ Time Frame: Assessed for up to 3.5 month ]
    During induction phase.
  • 10. Quality of life QLQ-C30 [ Time Frame: Assessed for up to 3.5 month ]
    During induction phase.
  • 11. Quality of life QLQ-C30 [ Time Frame: Assessed for up to 8 month ]
    As determined with EORTC QLQ-C30 determined from randomization.
  • 12. Adverse Events (AE) [ Time Frame: Assessed for up to 11.5 month ]
    Type, incidence, and severity according to NCI CTCAE version 4 with explicit consideration of any neurotoxicity.
  • 13. Adverse Events (AE) [ Time Frame: Assessed for up to 3.5 month ]
    Type, incidence, and severity according to NCI CTCAE version 4 with explicit consideration of any neurotoxicity during induction phase.
  • 14. Time of treatment without toxicity [ Time Frame: Assessed for up to 11.5 month ]
    Duration of treatment without toxicity leading to permanent discontinuation during induction and randomized phase.
  • 15. Time of treatment without toxicity [ Time Frame: Assessed for up to 3.5 month ]
    Duration of treatment during induction phase.
  • 16. Neurotoxicity Assessment FACT taxane score [ Time Frame: Assessed for up to 11.5 month ]
    Functional assessment of neurotoxicity (with FACT taxane score) during induction and randomized phase.
  • 17. Neurotoxicity Assessment FACT taxane score [ Time Frame: Assessed for up to 3.5 month ]
    Functional assessment of neurotoxicity (with FACT taxane score) during induction phase.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- Adult patients (≥ 18 years of age)

- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
Patients with islet cell neoplasms are excluded.

- Karnofsky Perfomance Status (KPS) ≥ 70%

- At least one unidimensionally measurable lesion as assessed by CT- scan or Magnetic
resonance imaging (MRI) according to Response Evaluation Criteria In Solid Tumors
(RECIST1.1 ),

- Total bilirubin ≤ 1.5 x ULN (Upper Limit of Normal). Patients with a biliary stent may
be included provided that bilirubin level after stent insertion decreased to ≤ 1.5 x
ULN and there is no cholangitis.

- Adequate renal, hepatic and bone marrow function, defined as

- Calculated creatinine clearance ≥ 30 mL/min according to CKD-EPI formula (Chronic
kidney Disease Epidemiology Collaboration)

- AST/GOT and/or ALT/GPT ≤ 2.5 x ULN and ≤ 5.0 x ULN in case of liver metastasis

- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L

- Haemoglobin ≥ 9 g/dL

- Platelets ≥ 100 x 100 x 10^9/L

- Females of Childbearing Potential (FCBP) must have a negative serum pregnancy test
within 7 days of the first application of study treatment and they must agree to
undergo further pregnancy tests before randomization and at the end of treatment visit
and

- FCBP must either agree to use and be able to take effective contraceptive birth
control measures (Pearl Index 5 years prior to
enrolment Hypersensitivity against nab-paclitaxel, gemcitabine, or any excipients of
these drugs

- Continuing abuse of alcohol, drugs, or medical drugs

- Pregnant females, breast feeding females or females of childbearing potential unable
to perform adequate contraceptive measures or practice complete abstinence from
heterosexual intercourse

- Participation in any other clinical trial or treatment with any experimental drug
within 28 days before enrolment to the study or during study participation until the
end of treatment visit.

Contacts and Locations

Contacts

Contact: Saskia Schulze, M.Sc. Saskia.Schulze@aio-studien-ggmbh.de

Contact: Frank Kullmann, Prof. Dr. frank.kullmann@kliniken-nordoberpfalz.ag

Locations

Germany
Kliniken Nordoberpfalz AG, Klinikum Weiden
Weiden

Sponsors and Collaborators

AIO-Studien-gGmbH

ClinAssess GmbH

Celgene Corporation

Investigators

Principal Investigator: Frank Kullmann, Prof. Dr. Kliniken Nordoberpfalz AG Klinikum Weiden Medizinische Kliniken I

More Information

  • Responsible Party: AIO-Studien-gGmbH
  • ClinicalTrials.gov Identifier: NCT02564146 History of Changes
  • Other Study ID Numbers: AIO-PAK-0114, 2014-004086-24, AX-CL-PANC-AIO-004415
  • First Posted: September 30, 2015 Key Record Dates
  • Last Update Posted: April 29, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Additional relevant MeSH terms: Pancreatic Neoplasms