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Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cetuximab/Gemcitabine
Radiotherapy
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Stage I, II, III pancreatic adenocarcinoma, Radiographically measurable disease

Eligibility Criteria

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

Inclusion Criteria: Histologic proof of pancreatic adenocarcinoma Clinical stage I, II, or III disease Radiographically measurable disease Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry Signed protocol consent Karnofsky performance status of at least 70% Age > or = to 18 years Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment. Absolute neutrophil count (ANC) > 1500; platelets > 100,000/ul. Creatinine < 1.5 x upper limit of normal (ULN) Bilirubin < 1.5 x ULN; AST < 2.5 x ULN. Exclusion Criteria: Acute hepatitis or known HIV Active or uncontrolled infection Significant history of cardiac disease Prior therapy which affects or targets the EGF pathway Prior severe infusion reaction to a monoclonal antibody Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents Any previous chemotherapy or abdominal or pelvic radiotherapy No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years. Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cetuximab, Gemcitabine, RT

    Arm Description

    weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy

    Outcomes

    Primary Outcome Measures

    Objective Response of Tumor by RECIST 1.0 Criteria
    Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.

    Secondary Outcome Measures

    Number of Participants Assessed for Adverse Events
    Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0
    Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy
    Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).
    Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.
    Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.
    Disease-Free Survival After Therapy
    Time to disease progression after therapy.
    Overall Length of Survival After Therapy
    Length of survival after therapy in all participants enrolled.
    Pattern of Failure After Therapy
    Local recurrence, distant recurrence, or both.

    Full Information

    First Posted
    September 22, 2005
    Last Updated
    July 10, 2014
    Sponsor
    Dartmouth-Hitchcock Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00225784
    Brief Title
    Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
    Official Title
    A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2005 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    September 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dartmouth-Hitchcock Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
    Detailed Description
    The study treatment for this protocol is Loading dose of Cetuximab 400 mg/m2 Weekly Cetuximab 250 mg/m2 Bi-weekly Gemcitabine 50 mg/m2 Daily Radiation for 28 fractions CT scan four weeks after completion of treatment Evaluation by surgeon for resectability

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer
    Keywords
    Stage I, II, III pancreatic adenocarcinoma, Radiographically measurable disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cetuximab, Gemcitabine, RT
    Arm Type
    Experimental
    Arm Description
    weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Cetuximab/Gemcitabine
    Other Intervention Name(s)
    Erbitux
    Intervention Description
    Once weekly Cetuximab, twice weekly Gemcitabine for six weeks
    Intervention Type
    Procedure
    Intervention Name(s)
    Radiotherapy
    Intervention Description
    Daily radiotherapy for 28 days
    Primary Outcome Measure Information:
    Title
    Objective Response of Tumor by RECIST 1.0 Criteria
    Description
    Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.
    Time Frame
    one month post-therapy
    Secondary Outcome Measure Information:
    Title
    Number of Participants Assessed for Adverse Events
    Description
    Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0
    Time Frame
    Participants were followed during treatment and for 30 days after completion of treatment
    Title
    Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy
    Description
    Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).
    Time Frame
    1 month after completion of treatment
    Title
    Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.
    Description
    Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.
    Time Frame
    One month post-therapy
    Title
    Disease-Free Survival After Therapy
    Description
    Time to disease progression after therapy.
    Time Frame
    Five years post treatment
    Title
    Overall Length of Survival After Therapy
    Description
    Length of survival after therapy in all participants enrolled.
    Time Frame
    Five years post treatment
    Title
    Pattern of Failure After Therapy
    Description
    Local recurrence, distant recurrence, or both.
    Time Frame
    Five years post treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologic proof of pancreatic adenocarcinoma Clinical stage I, II, or III disease Radiographically measurable disease Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry Signed protocol consent Karnofsky performance status of at least 70% Age > or = to 18 years Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment. Absolute neutrophil count (ANC) > 1500; platelets > 100,000/ul. Creatinine < 1.5 x upper limit of normal (ULN) Bilirubin < 1.5 x ULN; AST < 2.5 x ULN. Exclusion Criteria: Acute hepatitis or known HIV Active or uncontrolled infection Significant history of cardiac disease Prior therapy which affects or targets the EGF pathway Prior severe infusion reaction to a monoclonal antibody Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents Any previous chemotherapy or abdominal or pelvic radiotherapy No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years. Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    J Marc Pipas, MD
    Organizational Affiliation
    Dartmouth-Hitchcock Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

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