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

NCT00338039 | Completed Phase 2 Results

• 1 other identifier: 2004-0983
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Cetuximab; C225; Erbitux; Gemcitabine; Oxaliplatin; Eloxatin; Capecitabine; Xeloda

Outcome Measures

Primary Outcomes (2)

• Overall Survival Rate

  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.

  1 to 4 years

• Median Overall Survival

  Median survival is defined as the time of initiation of the first dose of chemotherapy to the date of death.

  Baseline to disease progression or death, up to 4 years

Study Arms (1)

Chemotherapy + Chemoradation

EXPERIMENTAL

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.

Drug: Cetuximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Radiotherapy

Interventions

Cetuximab DRUG

500 mg/m\^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy.

Also known as: C225, Erbitux, IMC-C225

Chemotherapy + Chemoradation

Gemcitabine DRUG

Induction Therapy: 1 gm/m\^2 over 100 minutes every 2 weeks +/-1 day for 4 doses. Chemotherapy Maintenance: 1 gm/m\^2/week over 100 minutes weekly for 3 weeks then 1 week off.

Also known as: Gemzar, Gemcitabine Hydrochloride

Chemotherapy + Chemoradation

Oxaliplatin DRUG

Induction Chemotherapy: 100 mg/m\^2 over 120 minutes every 2 weeks +/-1 day for 4 doses.

Also known as: Eloxatin

Chemotherapy + Chemoradation

Capecitabine DRUG

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.

Also known as: Xeloda

Chemotherapy + Chemoradation

Radiotherapy RADIATION

Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.

Also known as: XRT

Chemotherapy + Chemoradation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patients must be 18 years and older. There will be no upper age restriction
• Karnofsky performance status greater than or equal to 70 are eligible.
• 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.
• 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.
• Bone marrow function: absolute neutrophil count (ANC) \>1,500/ul. Platelets \>100,000/ul.
• Renal function: creatinine clearance \>30 mL/min (calculated with Cockcroft-Gault equation).
• 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.
• Neurologic function: neuropathy (sensory) \< Common Toxicity Criteria (CTC) Grade 2.
• Patients must sign a study-specific consent form, which is attached to this protocol.

You may not qualify if:

• Patients with a history of prior metastatic cancer.
• Patients must not have significant infection,i.e., requiring intravenous (IV) antibiotics, or other coexistent medical condition that would preclude protocol therapy.
• 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%.
• Prior therapy which specifically and directly targets the estimated EGFR pathway.
• Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) to a monoclonal antibody.
• Any prior history of radiotherapy to the abdomen.
• 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)
• Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
• Patients who have had an organ allograft.
• Patients on Coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine. Low dose (1 mg) Coumadin is allowed.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas (UT) MD Anderson Cancer Center official website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cetuximab; Gemcitabine; Oxaliplatin; Capecitabine; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics

Results Point of Contact

• Title: Christopher H. Crane, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Christopher H. Crane, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2006
• First Posted: June 20, 2006
• Study Start: September 1, 2005
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 22, 2013
• Results First Posted: March 22, 2013

Record last verified: 2013-02

Locations

US (1)