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

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ClinicalTrials.gov Identifier: NCT02564146
Recruitment Status : Active, not recruiting
First Posted : September 30, 2015
Last Update Posted : July 21, 2021
Sponsor:
Collaborators:
ClinAssess GmbH
Celgene Corporation
Information provided by (Responsible Party):
AIO-Studien-gGmbH

Tracking Information
First Submitted Date  ICMJE September 29, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date July 21, 2021
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
  • Overall survival (OS) [ Time Frame: 3.5 month ]
    During induction phase.
  • Overall survival (OS) [ Time Frame: 42 month ]
    Determined from first application of induction treatment.
  • Progression-free survival (PFS) [ Time Frame: 3.5 month ]
    During induction phase.
  • 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.
  • 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.
  • Overall response rate (ORR) [ Time Frame: Assessed for up to 42 month ]
    According to RECISTv1.1 determined from first application of induction treatment.
  • Overall response rate (ORR) [ Time Frame: Assessed for up to 3.5 month ]
    During induction phase.
  • Disease control rate (DCR) [ Time Frame: Assessed for up to 42 month ]
    According to RECISTv1.1 determined from first application of induction treatment.
  • Disease control rate (DCR) [ Time Frame: Assessed for up to 3.5 month ]
    During induction phase.
  • Quality of life QLQ-C30 [ Time Frame: Assessed for up to 3.5 month ]
    During induction phase.
  • Quality of life QLQ-C30 [ Time Frame: Assessed for up to 8 month ]
    As determined with EORTC QLQ-C30 determined from randomization.
  • 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.
  • 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.
  • 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.
  • Time of treatment without toxicity [ Time Frame: Assessed for up to 3.5 month ]
    Duration of treatment during induction phase.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • Overall survival (OS) [ Time Frame: 3,5 month ]
    During induction phase.
  • Overall survival (OS) [ Time Frame: 42 month ]
    Determined from first application of induction treatment.
  • Progression-free survival (PFS) [ Time Frame: 3,5 month ]
    During induction phase.
  • 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.
  • 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.
  • Overall response rate (ORR) [ Time Frame: Assessed for up to 42 month ]
    According to RECISTv1.1 determined from first application of induction treatment.
  • Overall response rate (ORR) [ Time Frame: Assessed for up to 3,5 month ]
    During induction phase.
  • Disease control rate (DCR) [ Time Frame: Assessed for up to 42 month ]
    According to RECISTv1.1 determined from first application of induction treatment.
  • Disease control rate (DCR) [ Time Frame: Assessed for up to 3,5 month ]
    During induction phase.
  • Quality of life QLQ-C30 [ Time Frame: Assessed for up to 3,5 month ]
    During induction phase.
  • Quality of life QLQ-C30 [ Time Frame: Assessed for up to 8 month ]
    As determined with EORTC QLQ-C30 determined from randomization.
  • 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.
  • 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.
  • 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.
  • Time of treatment without toxicity [ Time Frame: Assessed for up to 3,5 month ]
    Duration of treatment during induction phase.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-line Treatment of Metastatic Pancreatic Cancer With Nab-paclitaxel and Gemcitabine
Official Title  ICMJE 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
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Pancreatic Cancer
  • Adenocarcinoma of the Pancreas
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • 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

    Intervention: Drug: nab-paclitaxel and gemcitabine
  • 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

    Interventions:
    • Drug: nab-paclitaxel and gemcitabine
    • Drug: gemcitabine mono and nab-paclitaxel and gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 29, 2015)
325
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 < 1) or agree to practice complete abstinence from heterosexual intercourse during the course of the study and for at least 1 month after last application of study treatment. A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 years, or unless she is surgically sterile.
  • Males must agree not to father a child during the course of the trial and for at least 6 months after last administration of study drugs.
  • Signed and dated informed consent before the start of any specific protocol procedures Patient's legal capacity to consent to study participation

Exclusion Criteria:

  • Missing histological or cytological confirmation of metastatic adenocarcinoma of the pancreas Locally advanced pancreatic adenocarcinoma without metastases Any previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. (Prior adjuvant chemotherapy with gemcitabine or fluoropyrimidine in curative intent is allowed if terminated more than 6 months before first application of study treatment. Previous palliative radiotherapy of bonemetastases for alleviation of pain is permitted provided that irradiated bone metastases are no target lesions.) Known brain metastase/brain metastases. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
  • Pre-existing peripheral neuropathy ≥ grade 2 according to CTCAE version 4 (Common Terminology Criteria for Adverse Events)
  • • Medical history of interstitial lung disease (ILD) or pulmonary fibrosis
  • Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
  • Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
  • Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the study and his/her safety during the study or interfere with interpretation of study results e.g. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders Previous or concurrent tumor other than underlying tumor disease (pancreatic cancer) with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated tumors > 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02564146
Other Study ID Numbers  ICMJE AIO-PAK-0114
2014-004086-24 ( EudraCT Number )
AX-CL-PANC-AIO-004415 ( Other Grant/Funding Number: Celgene )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AIO-Studien-gGmbH
Study Sponsor  ICMJE AIO-Studien-gGmbH
Collaborators  ICMJE
  • ClinAssess GmbH
  • Celgene Corporation
Investigators  ICMJE
Principal Investigator: Frank Kullmann, Prof. Dr. Kliniken Nordoberpfalz AG Klinikum Weiden Medizinische Kliniken I
PRS Account AIO-Studien-gGmbH
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP