Adenocarcinoma Of The Pancreas Treated With Panitumumab And Gemcitabine Regimen To Investigate Overall Survival As Primary Endpoint

Study Overview

Adenocarcinoma of the Pancreas Treated With Panitumumab and Gemcitabine Regimen to Investigate Overall Survival as Primary Endpoint

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.

Enrollment closed after 3 patients were enrolled. This voluntary action was prompted by the announcement that the Southwest Oncology Group (SWOG) S0205 trial (NCT00075686), A Phase III Randomized Open Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer, did not meet its primary endpoint of improving overall survival).

Cancer of Pancreas
Cancer of the Pancreas
Pancreas Cancer
Pancreatic Cancer

DRUG: Gemcitabine
DRUG: panitumumab

20060542

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-01-31	Results First Submitted 2010-08-06	Last Update Submitted that met QC Criteria 2013-11-15
First Submitted that Met QC Criteria 2008-01-31	Results First Submitted that Met QC Criteria 2013-11-15	Last Update Posted (ESTIMATED) 2014-01-06
First Posted (ESTIMATED) 2008-02-13	Results First Posted 2014-01-06	Last Verified 2013-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gemcitabine + panitumumab Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Da	DRUG: Gemcitabine Intravenous administration DRUG: panitumumab Intravenous administration

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gemcitabine + panitumumab

Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Da

DRUG: Gemcitabine

Intravenous administration

DRUG: panitumumab

Intravenous administration

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival at 1 Year	The survival time is calculated from Study Day 1 (ie, the first day that a participant receives study treatment with the gemcitabine regimen in combination with panitumumab) to the date of death due to any cause.	12 months

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free Survival	Progression-Free Survival was defined as the time from Study Day 1 to the date of disease progression or the date of death due to any cause (whichever comes earlier). Disease progression is determined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria or per physician's assessment based on symptom progression.	Up to 25 months
Percentage of Participants With Overall Response	Overall Response defined as the percentage of participants with complete or partial response (CR or PR), as defined by modified RECIST. CR: Disappearance of all target and non-target lesions. PR: Either at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameters (SLD) and no progression of existing non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.	Overall study

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
Patients with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, bilary, gastrointestinal bypass) are eligible, if the patient 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 upper limit of normal (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 International Ethics Committee/Institutional Review board (IEC/IRB)-approved informed consent form

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-Epidermal growth factor receptor (EGFr) antibody or Vascular endothelial growth factor (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
Patients 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). Patients receiving coumadin should have their International Normalized Ratio (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
Patient unwilling or unable to comply with study requirements
Patient 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: MD, Amgen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record