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Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gemcitabine
Capecitabine
Erlotinib
Sponsored by
PD Dr. med. Volker Heinemann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring capecitabine, gemcitabine, Erlotinib, pancreatic cancer, advanced

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 75 years
  • Histologically proven pancreatic cancer stage III or IV (T1-3 N1M0 or T1 3N0 1M1)
  • No option for resection with curative intent
  • At least one measurable or not measurable lesion (according to RECIST)
  • No previous chemotherapy or other systemic tumor therapy
  • No previous radiation
  • Performance-Status 0-2 according to WHO/ECOG
  • Life expectancy of at least 3 months
  • Adequate kidney-, liver- and bone marrow function, defined as
  • Absolute neutrophil count * 1,5 x 109/l
  • Hemoglobin * 8 g/dl
  • Thrombocytes * 100 x 109/l
  • Bilirubin * 2 x upper norm (with liver mets < 5-fold)
  • Serum Creatinine * 1,25 x upper norm
  • Creatinine clearance > 30 ml/min (Cockroft/Gault)
  • Transaminases * 2,5 x upper norm (with liver mets < 5-fold)
  • Possibility of regular long-term follow-up
  • Negative pregnancy test in women at childbearing age
  • All patients must have signed an informed consent before study entry.

Exclusion Criteria:

  • Known secondary cancer other than curatively treated basalioma or carcinoma in situ of the cervix uteri
  • Clinically unstable CNS-metastases
  • Known hypersensitivity against study medication
  • Severe impairment of renal function (creatinine clearance < 30 ml/min)
  • Severe impairment of liver function (bilirubin > 2,0 x above upper norm, transaminases > 2,5 x upper norm, or with known liver metastasis >5 x upper norm)
  • Clinically relevant disease of the cardiovascular system or other vital organs
  • Known polyneuropathy
  • Known DPD-deficiency (screening not required)
  • Simultaneous treatment with the antiviral agent sorivudin or chemically related agents such as brivudin
  • Pregnancy, lactation or lack of reliable contraception in women at childbearing age
  • Mental disease, drug- or alcohol abuse
  • Participation in another clinical trial within the last 4 weeks
  • All other diseases which may prevent adequate participation in the trial
  • Indication of lack of compliance with study regulations

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Arm A

    Arm B

    Arm Description

    Outcomes

    Primary Outcome Measures

    TTF2
    Time to treatment failure, after 2nd line (crossover) therapy

    Secondary Outcome Measures

    TTF1
    Time to treatment failure
    Remission Rate
    Overall Survival
    Clinical Benefit Response
    Tumor marker CA19-9 characteristics
    Quality of Life
    Toxicity

    Full Information

    First Posted
    February 22, 2007
    Last Updated
    July 5, 2012
    Sponsor
    PD Dr. med. Volker Heinemann
    Collaborators
    Roche Pharma AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00440167
    Brief Title
    Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine
    Official Title
    Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    PD Dr. med. Volker Heinemann
    Collaborators
    Roche Pharma AG

    4. Oversight

    5. Study Description

    Brief Summary
    This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer
    Keywords
    capecitabine, gemcitabine, Erlotinib, pancreatic cancer, advanced

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    280 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A
    Arm Type
    Active Comparator
    Arm Title
    Arm B
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Intervention Description
    Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28
    Intervention Type
    Drug
    Intervention Name(s)
    Capecitabine
    Intervention Description
    Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause ("Flat Dosing")
    Intervention Type
    Drug
    Intervention Name(s)
    Erlotinib
    Intervention Description
    Erlotinib 150 mg/d oral, daily without break
    Primary Outcome Measure Information:
    Title
    TTF2
    Description
    Time to treatment failure, after 2nd line (crossover) therapy
    Time Frame
    approximate 6 months after first line treatment
    Secondary Outcome Measure Information:
    Title
    TTF1
    Description
    Time to treatment failure
    Time Frame
    approximate 6 months after randomization
    Title
    Remission Rate
    Time Frame
    approximate 6 months after randomization
    Title
    Overall Survival
    Time Frame
    42 months after randomization
    Title
    Clinical Benefit Response
    Time Frame
    approximate 6 months after randomization
    Title
    Tumor marker CA19-9 characteristics
    Time Frame
    approximate 6 months after randomization
    Title
    Quality of Life
    Time Frame
    approximate 6 months after randomization
    Title
    Toxicity
    Time Frame
    approximate 6 months after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 18 and 75 years Histologically proven pancreatic cancer stage III or IV (T1-3 N1M0 or T1 3N0 1M1) No option for resection with curative intent At least one measurable or not measurable lesion (according to RECIST) No previous chemotherapy or other systemic tumor therapy No previous radiation Performance-Status 0-2 according to WHO/ECOG Life expectancy of at least 3 months Adequate kidney-, liver- and bone marrow function, defined as Absolute neutrophil count * 1,5 x 109/l Hemoglobin * 8 g/dl Thrombocytes * 100 x 109/l Bilirubin * 2 x upper norm (with liver mets < 5-fold) Serum Creatinine * 1,25 x upper norm Creatinine clearance > 30 ml/min (Cockroft/Gault) Transaminases * 2,5 x upper norm (with liver mets < 5-fold) Possibility of regular long-term follow-up Negative pregnancy test in women at childbearing age All patients must have signed an informed consent before study entry. Exclusion Criteria: Known secondary cancer other than curatively treated basalioma or carcinoma in situ of the cervix uteri Clinically unstable CNS-metastases Known hypersensitivity against study medication Severe impairment of renal function (creatinine clearance < 30 ml/min) Severe impairment of liver function (bilirubin > 2,0 x above upper norm, transaminases > 2,5 x upper norm, or with known liver metastasis >5 x upper norm) Clinically relevant disease of the cardiovascular system or other vital organs Known polyneuropathy Known DPD-deficiency (screening not required) Simultaneous treatment with the antiviral agent sorivudin or chemically related agents such as brivudin Pregnancy, lactation or lack of reliable contraception in women at childbearing age Mental disease, drug- or alcohol abuse Participation in another clinical trial within the last 4 weeks All other diseases which may prevent adequate participation in the trial Indication of lack of compliance with study regulations
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Volker Heinemann, MD
    Organizational Affiliation
    University of Munich - Klinikum Grosshadern
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32830200
    Citation
    Guenther M, Haas M, Heinemann V, Kruger S, Westphalen CB, von Bergwelt-Baildon M, Mayerle J, Werner J, Kirchner T, Boeck S, Ormanns S. Bacterial lipopolysaccharide as negative predictor of gemcitabine efficacy in advanced pancreatic cancer - translational results from the AIO-PK0104 Phase 3 study. Br J Cancer. 2020 Oct;123(9):1370-1376. doi: 10.1038/s41416-020-01029-7. Epub 2020 Aug 24. Erratum In: Br J Cancer. 2021 Aug;125(3):466.
    Results Reference
    derived
    PubMed Identifier
    25164437
    Citation
    Ormanns S, Siveke JT, Heinemann V, Haas M, Sipos B, Schlitter AM, Esposito I, Jung A, Laubender RP, Kruger S, Vehling-Kaiser U, Winkelmann C, Fischer von Weikersthal L, Clemens MR, Gauler TC, Marten A, Geissler M, Greten TF, Kirchner T, Boeck S. pERK, pAKT and p53 as tissue biomarkers in erlotinib-treated patients with advanced pancreatic cancer: a translational subgroup analysis from AIO-PK0104. BMC Cancer. 2014 Aug 28;14:624. doi: 10.1186/1471-2407-14-624.
    Results Reference
    derived
    PubMed Identifier
    22773551
    Citation
    Heinemann V, Vehling-Kaiser U, Waldschmidt D, Kettner E, Marten A, Winkelmann C, Klein S, Kojouharoff G, Gauler TC, von Weikersthal LF, Clemens MR, Geissler M, Greten TF, Hegewisch-Becker S, Rubanov O, Baake G, Hohler T, Ko YD, Jung A, Neugebauer S, Boeck S. Gemcitabine plus erlotinib followed by capecitabine versus capecitabine plus erlotinib followed by gemcitabine in advanced pancreatic cancer: final results of a randomised phase 3 trial of the 'Arbeitsgemeinschaft Internistische Onkologie' (AIO-PK0104). Gut. 2013 May;62(5):751-9. doi: 10.1136/gutjnl-2012-302759. Epub 2012 Jul 7.
    Results Reference
    derived

    Learn more about this trial

    Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine

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