Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: June 17, 2009
Last updated: June 20, 2009
Last verified: June 2009

RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving cetuximab together with trastuzumab may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when given together with cetuximab and to see how well it works in treating patients with metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.

Condition Intervention Phase
Pancreatic Cancer
Biological: cetuximab
Biological: trastuzumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy.

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recommended dose of trastuzumab when given with cetuximab (Phase I) [ Designated as safety issue: No ]
  • Objective response rate as assessed by RECIST criteria (Phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 67
Study Start Date: December 2008
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:



  • Determine the recommended dose of trastuzumab when given with cetuximab in patients with metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy. (Phase I)
  • Evaluate the objective response rate as assessed by RECIST criteria. (Phase II)


  • Evaluate the safety profile as assessed by NCI CTCAE v3.0.
  • Evaluate progression-free survival.
  • Evaluate overall survival.

OUTLINE: This is a multicenter, phase I dose-escalation study of trastuzumab followed by a phase II study.

Patients receive cetuximab IV over 1-2 hours and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic adenocarcinoma of the pancreas

    • Progressed after first-line or adjuvant gemcitabine-based chemotherapy
  • Measurable disease as assessed by RECIST criteria
  • No known brain metastasis or symptomatic carcinomatous leptomeningitis


  • WHO performance status 0-1
  • Life expectancy ≥ 3 months
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2.5 times ULN
  • ALT/AST ≤ 5 times ULN
  • LVEF ≥ 55%
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No significant comorbidities, including any of the following:

    • Cardiovascular disease
    • Documented history of congestive heart failure
    • Uncontrolled, high-risk arrhythmia
    • Angina pectoris requiring treatment
    • Clinically significant valvular disease
    • Evidence of transmural myocardial infarction by ECG
    • Uncontrolled hypertension
    • Active bleeding
    • Clinically significant active infection
    • Severe dyspnea at rest
    • Oxygen-dependency
  • No other malignancy except basal cell carcinoma of the skin
  • No severe hypersensitivity to cetuximab or trastuzumab
  • No medical or psychological condition that would preclude study completion or giving informed consent
  • No legal incapacity or limited legal capacity


  • See Disease Characteristics
  • No prior cetuximab or trastuzumab
  • No other concurrent experimental drugs or anticancer therapy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00923299

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Marc Ychou, MD, PhD    33-4-6761-3066    mychou@valdorel.fnclcc.fr   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Principal Investigator: Marc Ychou, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00923299     History of Changes
Other Study ID Numbers: CDR0000636018  CLCC-THERAPY  RECF0910  VA-2008/34  EUDRACT-2008-003988-39 
Study First Received: June 17, 2009
Last Updated: June 20, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2016