Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00225784
First received: September 22, 2005
Last updated: April 16, 2013
Last verified: October 2011
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: Cetuximab/Gemcitabine
Procedure: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Objective Response of Tumor by RECIST 1.0 Criteria [ Time Frame: one month post-therapy ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants were followed during treatment and for 30 days after completion of treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 month after completion of treatment ] [ Designated as safety issue: No ]
    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. [ Time Frame: One month post-therapy ] [ Designated as safety issue: No ]
    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 Frame: Five years post treatment ] [ Designated as safety issue: No ]
    Time to disease progression after therapy.

  • Overall Length of Survival After Therapy [ Time Frame: Five years post treatment ] [ Designated as safety issue: No ]
    Length of survival after therapy in all participants enrolled.

  • Pattern of Failure After Therapy [ Time Frame: Five years post treatment ] [ Designated as safety issue: No ]
    Local recurrence, distant recurrence, or both.


Enrollment: 37
Study Start Date: February 2005
Estimated Study Completion Date: December 2017
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225784

Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: J Marc Pipas, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00225784     History of Changes
Other Study ID Numbers: DMS 0432
Study First Received: September 22, 2005
Results First Received: August 22, 2012
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:
Stage I, II, III pancreatic adenocarcinoma
Radiographically measurable disease

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cetuximab
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 17, 2014