PhI Study of Erbitux & Gemcitabine w/Radiation Therapy for Locally Adv. Pancreas Ca

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00467116
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : May 18, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nipun Merchant, MD, Vanderbilt-Ingram Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Gemcitabine and cetuximab may make tumor cells more sensitive to radiation therapy. Giving gemcitabine together with cetuximab and radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine when given together with cetuximab and radiation therapy in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: cetuximab Drug: gemcitabine hydrochloride Radiation: radiation therapy Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of gemcitabine hydrochloride when administered with cetuximab and radiotherapy in patients with unresectable locally advanced pancreatic or periampullary region cancer.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of gemcitabine hydrochloride.

Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-7 and gemcitabine hydrochloride IV over 15-40 minutes once weekly in weeks 2-7. Patients also undergo radiotherapy 5 days a week in weeks 2-7. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed for 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 12-30 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Erbitux and Gemcitabine With Radiation Therapy for Locally Advanced Pancreas Cancer
Study Start Date : October 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Therapeutic Intervention Biological: cetuximab
400mg/m2 initial dose week 1; followed by 250mg/m2/weekly starting week 2 with gemcitabine at fixed dose rate (10 mg/m2/min) + XRT. Cetuximab will start 1 week prior to all other treatment.
Other Name: Erbitux

Drug: gemcitabine hydrochloride

Dose Level Gemcitabine dose Gemcitabine infusion

-1 150mg/m2 15 Minutes 0 200mg/m2 20 minutes

  1. 300mg/m2 30 minutes
  2. 400mg/m2 40 minutes
Other Name: Gemzar

Radiation: radiation therapy

50.4 Gy, 28 fractions, 5.5 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to encompass gross disease with a margin of 1-1.5 cm.

The prescription point will be designated at the intersection of the multiple beams.

There are no planned interruptions > 3 days.

Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: Weekly and 4 weeks after last dose of radiation ]

Secondary Outcome Measures :
  1. Dose-limiting toxicity [ Time Frame: Weekly and 4 weeks after last dose of radiation ]
  2. Toxicity [ Time Frame: Weekly and 4 weeks after last dose of radiation ]
  3. Tumor response rate [ Time Frame: 4 weeks after last dose of radiation and every 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the pancreas (head, body, or tail) or periampullary region, meeting both of the following criteria:

    • Unresectable disease
    • Locally advanced disease
  • Measurable or evaluable disease by CT scan or MRI
  • No evidence of metastatic disease outside of the planned irradiation field
  • ECOG performance status 0-2
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.5 g/dL
  • AST and ALT ≤ 5 times upper limit of normal
  • Bilirubin ≤ 2.0 mg/dL
  • Creatinine ≤ 2.0 mg/dL
  • No clinical indication of compromised function of nonirradiated kidney
  • No secondary malignancies within the past 5 years except for resected nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion Criteria:

  • No acute hepatitis
  • No known HIV infection
  • No other active or uncontrolled infection
  • No significant history of uncontrolled cardiac disease, including any of the following:

    • Hypertension
    • Unstable angina
    • Myocardial infarction within the past 6 months
    • Congestive heart failure
    • Cardiomyopathy with decreased ejection fraction
  • No prior severe infusion reaction to a monoclonal antibody


  • No prior radiotherapy to planned field of treatment
  • No prior therapy that specifically and directly targets EGFR pathway
  • At least 14 days since prior surgery or biopsy
  • At least 28 days since prior bypass procedures
  • More than 5 years since prior and no other concurrent chemotherapy
  • No other concurrent investigational agent

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 identifier (NCT number): NCT00467116

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Nipun B. Merchant Vanderbilt-Ingram Cancer Center

Responsible Party: Nipun Merchant, MD, Professor of Surgery and Cancer Biology; Gastrointestinal Surgical Oncologist, Vanderbilt-Ingram Cancer Center Identifier: NCT00467116     History of Changes
Other Study ID Numbers: VICC GI 0466
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by Nipun Merchant, MD, Vanderbilt-Ingram Cancer Center:
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage II pancreatic cancer
recurrent pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents