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Adenocarcinoma of the Pancreas Treated With Panitumumab and Gemcitabine Regimen to Investigate Overall Survival as Primary Endpoint
This study has been terminated.
( APPRISE closure prompted by SWOG S0205 not meeting primary endpoint-improving OS. APPRISE enrollment closure due to similar design;no unexpected safety data )
First Received: January 31, 2008   Last Updated: August 20, 2009   History of Changes
Sponsor: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00613730
  Purpose

This is a phase II, multi-center, open-label, single-arm clinical trial to be conducted in the United States. In approximately 55 centers, approximately 75 eligible locally advanced unresectable or metastatic pancreatic cancer subjects will be enrolled to receive first-line therapy of gemcitabine and panitumumab.


Condition Intervention Phase
Cancer of Pancreas
Cancer of the Pancreas
Pancreas Cancer
Pancreatic Cancer
Drug: Gemcitabine
Drug: panitumumab
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II, Multi-center, Open-label, Single-Arm Study Using Gemcitabine and Panitumumab in the First-line Treatment of Subjects With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To estimate the overall survival (OS) in subjects with locally advanced unresectable or metastatic adenocarcinoma of the pancreas using gemcitabine and panitumumab as first-line treatment. [ Time Frame: Assessment at week 9 and Q4W thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To estimate: Progression-free survival (PFS), overall response rate, and preliminary safety profiles [ Time Frame: Assessment at week 9 and Q4W thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: January 2007
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gemcitabine + panitumumab: Experimental
SIngle Arm Trial
Drug: Gemcitabine
Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 over 30 minutes, on day 1, once weekly for 7 weeks followed by a 1 week rest. Subsequent cycles consist of injections, on day 1, once weekly for 3 consecutive weeks out of every 4 weeks.
Drug: panitumumab
Panitumumab 6 mg/kg will be infused, intravenously, over 1 hour ± 15 minutes on day 1 of weeks 1, 3, 5, 7, and Q2W on days 1 and 15 of each subsequent chemotherapy cycle, immediately, before starting chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women ≥ 18 and ≤ 75 years of age
  • Histologically or cytologically confirmed pancreatic adenocarcinoma meeting one of the following criteria: Locally advanced unresectable disease, or metastatic disease
  • Measurable or unmeasurable disease
  • Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, bilary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and ≥ 28 days has passed since the operation. Patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence
  • Karnofsky performance score ≥ 60 %
  • Life expectancy of ≥ 12 weeks as documented by the investigator
  • Hematologic function, as follows: Absolute neutrophils count (ANC) ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, and hemoglobin ≥ 9.0 g/dL
  • Renal function, as follows: Serum creatinine ≤ 1.5 mg/dL
  • Hepatic function, as follows: Aspartate aminotransferase (AST) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN), alanine aminotransferase (ALT) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN), and total bilirubin ≤ 2.0 mg/dL. Patients with history of biliary obstruction are eligible after intervention, once this criteria is met.
  • Metabolic function, as follows: Magnesium ≥ lower limit of normal, and calcium ≥ lower limit of normal
  • Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form

Exclusion Criteria:

  • Islet cell or acinar cell carcinoma or cystadenocarcinoma
  • History or known presence of central nervous system (CNS) mestatases
  • History of another primary cancer, except: Curatively treated cervical carcinoma in situ, or curatively resected non-melanomatous skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 3 years prior to enrollment
  • Other concurrent anticancer chemotherapy
  • Concomitant malignant disease
  • Prior radiotherapy ≤ 14 days, or if subjects has not recovered from radiotherapy
  • Uncontrolled seizure disorder or other serious neurological diseases
  • Any co-morbid disease that would increase risk of toxicity
  • Prior anti-EGFr antibody or VEGF therapy (eg, cetuximab, bevacizumab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
  • Adjuvant chemotherapy or chemoradiotherapy ≥ 24 weeks prior to enrollment
  • Prior treatment with gemcitabine
  • Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
  • Regular use (as determined by the investigator) of nonsteroidal anti-inflammatory agents
  • Known allergy to panitumumab or any components of panitumumab formulation or gemcitabine
  • Recent infection requiring a course of systemic anti-infectives that was completed ≤ 14 days before enrollment (exception can be made at the judgment of the investigator for oral treatment of an uncomplicated urinary tract infection [UTI])
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year prior to enrollment
  • History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease) on screening chest x-ray or computed tomography (CT) scan
  • Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to enrollment
  • Pre-existing bleeding diathesis or coagulopathy with the exception of well-controlled chronic anticoagulation (eg, coumadin or heparin therapy). Subjects receiving coumadin should have their INR monitored closely
  • History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
  • Subject unwilling or unable to comply with study requirements
  • Subject who is pregnant or breast feeding
  • Man or woman of child bearing potential (women who are post menopausal < 52 weeks, not surgically sterilized, or not abstinent) who do not consent to use adequate contraceptive precautions (per institutional standard of care) during the course of the study and for 24 weeks for women and 4 weeks for men, after the last dose of gemcitabine or panitumumab, whichever dose is last
  • Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
  • Major surgery ≤ 28 days or minor surgery ≤ 14 days prior to enrollment
  • Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613730

Locations
United States, Florida
Research Site
Boynton Beach, Florida, United States
United States, Kentucky
Research Site
Paducah, Kentucky, United States
United States, Maryland
Research Site
Clinton, Maryland, United States
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20060542
Study First Received: January 31, 2008
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00613730     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2009