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Induction Cetuximab (IM-C225), Gemcitabine and Oxaliplatin, Followed by Radiotherapy With Concurrent Capecitabine, and Cetuximab, Followed by Maintenance Cetuximab and Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

Induction Cetuximab (IM-C225), Gemcitabine and Oxaliplatin, Followed by Radiotherapy With Concurrent Capecitabine, and Cetuximab, Followed by Maintenance Cetuximab and Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

Cetuximab is a drug that blocks epidermal growth factor receptor (EGFR). EGFR may be
involved in certain types of cancer. When EGFR is stimulated, a series of chemical
reactions starts that results in a tumor being "told" to grow. Cetuximab tries to stop
these reactions by blocking EGFR. This may stop tumors from growing. Cetuximab has been
shown to increase the effect of chemotherapy and of radiation therapy, both of which will
also be given in this study.

Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in the
study. You will have a complete medical history and physical exam. Blood (about 2
tablespoons) and urine will be collected for routine tests. Chest x-rays and computed
tomography (CT) scans of the abdomen will be done. Women who are able to have children must
have a negative urine pregnancy test.

If you are found to be eligible to take part in this study, you will first receive cetuximab
every 2 weeks for 8 weeks (4 doses). Cetuximab will be given every 2 weeks throughout the
duration of the study. Cetuximab will be continued during the radiation and capecitabine
combination, during the retesting stage and then during the chemotherapy that is given after
radiation therapy. Cetuximab infusions will be given over approximately 2 hours.
Gemcitabine and oxaliplatin chemotherapy will be given once every 2 weeks (4 doses) for 8
weeks. Both drugs are given through a central line and over about 2 hours. Cetuximab will be
given first, followed by gemcitabine, and then followed by oxaliplatin. A CT scan and chest
X-ray will be done 2 weeks after the last dose (at Week 10).

As long as the tumor has not grown or spread, you will then receive cetuximab, capecitabine,
and radiation therapy together. The Capecitabine will be given by mouth twice a day every
day of radiation therapy (5 and 1/2 weeks). Radiation therapy will be given once a day for
5 days in a row. It will be given for 5 and 1/2 weeks or 28 treatments. The radiation will
be given from 4 directions and focused on the tumor while you are lying on your back. You
will continue to receive cetuximab by vein once every 2 weeks during capecitabine and
radiation therapy.

After radiotherapy, you will continue to take cetuximab by vein every 2 weeks. The effect
of treatment will be evaluated 5-6 weeks after the completion of radiation therapy and
capecitabine. A chest x-ray and CT scans will be performed, and about 2 tablespoons of blood
will be drawn for routine testing. As long as the tumor has not grown or spread and the side
effects are not too severe, you may continue to receive Cetuximab by vein once every 2 weeks
. You will also receive Gemcitabine by vein in the same dose as before for 3 out of every 4
weeks as long as the tumor does not grow and the side effects are not too severe. CT scans
and chest x-rays will then be done every 2 months to evaluate the status of the tumor.

During the study, you will have physical exams, including weekly blood tests (about 2
tablespoons) each. The possible development of side effects will be closely monitored and
could require extra blood and/or urine samples.

You will be taken off study if your disease gets worse or intolerable side effects occur.
You may have surgery if at any time during therapy the tumor can be removed surgically. A
separate consent form will be used for that situation.

This is an investigational study. Capecitabine, oxaliplatin, and cetuximab are approved by
the FDA for colon cancer but have not been approved by the FDA for pancreatic cancer. Up to
69 patients will take part in this multicenter study. Up to 60 will be enrolled at M. D.

Inclusion Criteria:

1. Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to
treatment. Patients can have tumor originating in any part of the pancreas. Islet
cell tumors are not eligible. Only patients with non- metastatic, unresectable
disease (AJCC 2002 stage T4 NX M0) are eligible. Computed Tomography (CT) findings of
lung, liver, peritoneal metastasis are equivocal, are eligible. Patients who cannot
undergo resection because of underlying medical problems are also eligible. Diagnosis
of Pancreatic Adenocarcinoma by bile duce brushings are acceptable. Patients with
regional nodal disease are eligible.

2. All patients must be staged with a physical exam, chest X-ray (CXR), and
contrast-enhanced helical thin-cut abdominal CT. Unresectability is defined by CT
criteria: a) evidence of tumor extension to the celiac axis or superior mesenteric
(SM) artery, or b) evidence on either CT or angiogram of occlusion of the SM vein or
SM/ portal vein confluence. If a tumor does not meet this definition and is found to
be unresectable at surgical exploration, then that tumor is considered unresectable.

3. Patients must be 18 years and older. There will be no upper age restriction

4. Karnofsky performance status greater than or equal to 70 are eligible.

5. Patients must either be not of child bearing potential or have a negative urine
pregnancy test within 72 hours of treatment. Patients are considered not of child
bearing potential if they are surgically sterile (they have undergone a hysterectomy,
bilateral tubal ligation or bilateral oophorectomy) or they have been postmenopausal
for at least 12 months.

6. Women of childbearing potential must agree to practice adequate contraception and to
refrain from breast-feeding, as specified in the informed consent. Sexually active
males must practice contraception during the study.

7. Bone marrow function: absolute neutrophil count (ANC) >1,500/ul. Platelets

8. Renal function: creatinine clearance >30 mL/min (calculated with Cockcroft-Gault

9. Hepatic function: Total bilirubin less than 5mg/dL. If the patient required an
endobiliary stent, the bilirubin level must have declined on consecutive measurements
indicating adequate biliary decompression; alanine aminotransferase (ALT) less than
or equal to 5 times the upper limit of normal.

10. Neurologic function: neuropathy (sensory) < Common Toxicity Criteria (CTC) Grade 2.

11. Patients must sign a study-specific consent form, which is attached to this protocol.

Exclusion Criteria:

1. Patients with a history of prior metastatic cancer.

2. Patients must not have significant infection,i.e., requiring intravenous (IV)
antibiotics, or other coexistent medical condition that would preclude protocol

3. Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
congestive heart failure, and cardiomyopathy with ejection fraction less than <30%.

4. Prior therapy which specifically and directly targets the estimated EGFR pathway.

5. Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension)
to a monoclonal antibody.

6. Any prior history of radiotherapy to the abdomen.

7. History or evidence upon physical examination of central nervous system (CNS) disease
(e.g., primary brain tumor, seizures not controlled with standard medical therapy,
any brain metastases, or history of stroke)

8. Prior unanticipated severe reaction to fluoropyrimidine therapy or known
hypersensitivity to 5-fluorouracil.

9. Patients who have had an organ allograft.

10. Patients on Coumadin must be changed to Lovenox at least 1 week prior to starting
capecitabine. Low dose (1 mg) Coumadin is allowed.

11. Patients taking Sorivudine or Brivudine A must be off of these drugs for 4 weeks
prior to starting capecitabine. Patients taking cimetidine must have this drug
discontinued. Ranitidine or a drug from another anti-ulcer class can be substituted
for cimetidine if necessary.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival Rate

Outcome Description:

1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment.

Outcome Time Frame:

1 to 4 years

Safety Issue:


Principal Investigator

Christopher H. Crane, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2005

Completion Date:

June 2011

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Cetuximab
  • C225
  • Erbitux
  • Gemcitabine
  • Oxaliplatin
  • Eloxatin
  • Capecitabine
  • Xeloda
  • Pancreatic Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030