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 (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00601627
First received: January 18, 2008
Last updated: July 1, 2015
Last verified: July 2015
  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: Intervention Model: Single Group Assignment
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • 1-year survival rate [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: baseline to 2 years ] [ Designated as safety issue: No ]
    Survival time is defined as the time from registration to death due to any cause.

  • Time to disease progression [ Time Frame: baseline to 2 years ] [ Designated as safety issue: No ]
    Time to disease progression is defined as the time from registration to the earliest documented evidence of disease progression.

  • Confirmed response rate [ Time Frame: baseline to 2 years ] [ Designated as safety issue: No ]

    A confirmed tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.

    Confirmed tumor response will be evaluated using the first 6 cycles of treatment.


  • Duration of response [ Time Frame: baseline to 2 years ] [ Designated as safety issue: No ]
    Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is irst noted to be either a CR or PR to the earliest date progression is documented

  • Time to treatment failure [ Time Frame: baseline to 2 years ] [ Designated as safety issue: No ]
    Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.


Enrollment: 52
Study Start Date: June 2009
Study Completion Date: May 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panitumumab

Chemotherapy concurrent with radiation: Radiation 5 days per week for 5½ weeks; Panitumumab on days 1, 15, and 29 of radiation therapy 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.

4-6 weeks after completion of radiation therapy: Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; Panitumumab on days 1 and 15 of each cycle, for 3 cycles. Maintenance therapy: Panitumumab on days 1 and 15 of each cycle, for 6 cycles.

Biological: panitumumab Drug: capecitabine Drug: fluorouracil Drug: gemcitabine hydrochloride Radiation: radiation therapy

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:

  • Eastern Cooperative Oncology Group (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 North Central Cancer Treatment Group (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
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: George P. Kim, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00601627     History of Changes
Other Study ID Numbers: NCCTG-N064A, NCI-2009-01088, CDR0000584104
Study First Received: January 18, 2008
Last Updated: July 1, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer

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

ClinicalTrials.gov processed this record on August 27, 2015