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Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00225784
Recruitment Status : Completed
First Posted : September 26, 2005
Results First Posted : April 18, 2013
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Cetuximab/Gemcitabine Procedure: Radiotherapy Phase 2

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas
Study Start Date : February 2005
Actual Primary Completion Date : February 2010
Actual Study Completion Date : September 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Cetuximab, Gemcitabine, RT
weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
 Drug: Cetuximab/Gemcitabine
Once weekly Cetuximab, twice weekly Gemcitabine for six weeks
Other Name: Erbitux

Procedure: Radiotherapy
Daily radiotherapy for 28 days


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response of Tumor by RECIST 1.0 Criteria [ Time Frame: one month post-therapy ]
    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 :
  1. Number of Participants Assessed for Adverse Events [ Time Frame: Participants were followed during treatment and for 30 days after completion of treatment ]
    Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0

  2. Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy [ Time Frame: 1 month after completion of treatment ]
    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).

  3. Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment. [ Time Frame: One month post-therapy ]
    Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.

  4. Disease-Free Survival After Therapy [ Time Frame: Five years post treatment ]
    Time to disease progression after therapy.

  5. Overall Length of Survival After Therapy [ Time Frame: Five years post treatment ]
    Length of survival after therapy in all participants enrolled.

  6. Pattern of Failure After Therapy [ Time Frame: Five years post treatment ]
    Local recurrence, distant recurrence, or both.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225784


Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: J Marc Pipas, MD Dartmouth-Hitchcock Medical Center
More Information
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Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00225784    
Other Study ID Numbers: DMS 0432
First Posted: September 26, 2005    Key Record Dates
Results First Posted: April 18, 2013
Last Update Posted: July 16, 2014
Last Verified: October 2011
Keywords provided by Dartmouth-Hitchcock Medical Center:
Stage I, II, III pancreatic adenocarcinoma
Radiographically measurable disease
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cetuximab
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological