Panitumumab, Chemotherapy, and External-Beam Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot be Removed by Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00601627
First received: January 18, 2008
Last updated: June 17, 2012
Last verified: August 2010
  Purpose

RATIONALE: Monoclonal antibodies, such as panitumumab, 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. Drugs used in chemotherapy, such as fluorouracil, capecitabine, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Panitumumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor and make tumor cells more sensitive to radiation therapy. Giving panitumumab together with chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving panitumumab together with chemotherapy and external-beam radiation therapy works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.


Condition Intervention Phase
Pancreatic Cancer
Biological: panitumumab
Drug: capecitabine
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Panitumumab, Chemotherapy, and External Beam Radiation in Patients With Locally Advanced Pancreatic Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 1-year survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Confirmed response rate [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: June 2009
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the 1-year survival rate in patients with locally advanced pancreatic cancer treated with panitumumab and continuous infusion fluorouracil administered concurrently with external-beam radiotherapy followed by gemcitabine and panitumumab.

Secondary

  • To determine overall survival, time to disease progression, confirmed response rate, duration of response, and time to treatment failure in patients treated with this regimen.
  • To determine adverse events in patients treated with this regimen.

OUTLINE:

  • Panitumumab and chemoradiotherapy : Patients undergo external-beam radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Patients also receive panitumumab IV over 1 hour on days 1, 15, and 29 and fluorouracil IV continuously over 24 hours daily OR oral capecitabine twice daily beginning on day 1 and continuing through the last day of radiotherapy.
  • Panitumumab and chemotherapy: Beginning 4-6 weeks after completion of panitumumab and chemoradiotherapy, patients receive panitumumab IV over 1 hour on days 1 and 15 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses. Patients then proceed to maintenance therapy.
  • Maintenance therapy: Patients receive panitumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed unresectable adenocarcinoma of the pancreas

    • Including subtotal resection and gross residual disease

      • No microscopic residual disease only
  • Measurable disease is not required
  • Disease is encompassable within standard radiotherapy fields for pancreatic cancer
  • No evidence of metastatic disease outside of the planned radiotherapy field
  • No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
  • No distant metastases (i.e., liver or lung metastases or peritoneal spread)
  • No history or known presence of CNS metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 3 times upper limit of normal (ULN)* NOTE: *Biliary stent placement or surgical bypass should be considered prior to treatment if impending bile duct obstruction by tumor
  • AST ≤ 3 times ULN
  • Creatinine ≤ 2.0 times ULN
  • Magnesium normal
  • Willing to return to an NCCTG institution for follow-up
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after treatment with panitumumab
  • No prior or concurrent malignancy unless disease-free ≥ 3 years except for non-melanoma skin cancer, carcinoma in situ of the cervix, or organ confined prostate cancer with Gleason score < 7
  • No nausea or vomiting > grade 1
  • No uncontrolled intercurrent illness including, but not limited to, any the following:

    • Ongoing or active infection
    • Psychiatric illness or social situations that would limit compliance with study requirements
  • No New York Heart Association clinically significant cardiovascular disease ≥ grade 2, including any of the following within the past year:

    • Myocardial infarction
    • Unstable angina
    • Symptomatic congestive heart failure
    • Serious, uncontrolled cardiac arrhythmia
  • No known HIV positivity
  • No known hepatitis C virus or acute or chronic active hepatitis B infection
  • Adequate oral nutrition

PRIOR CONCURRENT THERAPY:

  • More than 21 days since prior laparotomy
  • No prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab)
  • No prior small molecule EGFR inhibitors (e.g., gefitinib, erlotinib, or lapatinib)
  • No prior radiotherapy that would overlap with planned radiotherapy fields
  • No prior or other concurrent chemotherapy
  • No prior or other concurrent biologic therapy
  • More than 4 weeks since prior and no concurrent or planned participation in another experimental drug study except studies with specific interventions intended to treat rashes associated with EGFR agents (e.g., N05C4)
  • No concurrent enteral hyperalimentation
  • No concurrent chronic immunosuppressive agents (e.g., methotrexate, cyclosporine, or corticosteroids)
  • No concurrent colony-stimulating factors during the first course of therapy
  • No other concurrent immunotherapy or radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601627

  Show 281 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: George P. Kim, MD Mayo Clinic
Investigator: John W. Bollinger, MD MeritCare Bemidji
Investigator: Daniel G. Petereit, MD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

Responsible Party: Jan C. Buckner, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00601627     History of Changes
Other Study ID Numbers: CDR0000584104, NCCTG-N064A
Study First Received: January 18, 2008
Last Updated: June 17, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Gemcitabine
Capecitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 19, 2014