Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients

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Brief Title

Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients

Official Title

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

Brief Summary

      The primary objective is to evaluate the efficacy of a combination of cetuximab with systemic
      chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. The primary
      endpoint is actuarial one-year survival.

      The secondary objectives are:

        -  To evaluate the local tumor response in patients treated with the above regimen.

        -  To characterize the safety of the above regimen.
    

Detailed Description

      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.
      Anderson.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Survival Rate


Condition

Pancreatic Cancer

Intervention

Cetuximab

Study Arms / Comparison Groups

 Chemotherapy + Chemoradation
Description:  Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

69

Start Date

September 2005

Completion Date

June 2011

Primary Completion Date

June 2011

Eligibility Criteria

        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
             >100,000/ul.

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

          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
             therapy.

          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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christopher H. Crane, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00338039

Organization ID

2004-0983


Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 Bristol-Myers Squibb

Study Sponsor

Christopher H. Crane, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

February 2013