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A Phase II Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma

This study has been terminated.
(Extreme toxicity of Pertuzumab and Erlotinib combination)
Genentech, Inc.
Information provided by (Responsible Party):
George Albert Fisher, Stanford University Identifier:
First received: April 20, 2010
Last updated: November 6, 2012
Last verified: October 2011
A phase II study combining pertuzumab with erlotinib for patients with gemcitabine refractory pancreatic adenocarcinoma

Condition Intervention Phase
Pancreatic Cancer
Drug: Pertuzumab
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Overall response rate by RECIST criteria [ Time Frame: CT imaging every 9 weeks while on protocol ]
  • Progression-free survival by RECIST criteria [ Time Frame: CT imaging every 9 weeks while on protocol ]
  • Overall survival [ Time Frame: 1 year ]
  • Quality of life assessment by EORTC QLQ-C30 questionnaire [ Time Frame: questionnaire every 3 weeks with study visit while on protocol ]
  • Toxicities assessed by CTCAE grading criteria v3.0 [ Time Frame: assessment every 3 weeks with study visit while on protocol ]
  • 50% decrease in CA19-9 from baseline [ Time Frame: blood draw every 3 weeks while in protocol ]

Enrollment: 1
Study Start Date: July 2010
Study Completion Date: March 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab, Erlotinib Hydrochloride Drug: Pertuzumab
iv, 840 mg, 420 mg
Other Names:
  • 2C4
  • Omnitarg
Drug: Erlotinib
PO, 150 mg
Other Names:
  • Erlotinib hydrochloride
  • Tarceva

Detailed Description:
A single-institution, single-arm phase II study investigating pertuzumab and erlotinib as a palliative regimen in the treatment of locally-advanced or metastatic pancreatic adenocarcinoma. To qualify for the trial, patients will require prior treatment with and disease progression through gemcitabine. Pertuzumab infusion will be administered every 21 days, while erlotinib tablets will be taken daily. Patients will receive CT scans at baseline and prior to every 3rd cycle.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

3.1 Inclusion Criteria

3.1.1 Histologically-confirmed pancreatic adenocarcinoma

3.1.2 One or more locally-advanced or metastatic lesions measurable in at least one dimension by modified RECIST criteria (v1.1)^13 within 4 weeks prior to entry of study

3.1.3 Prior therapy (1 or more): Disease progression following therapy with gemcitabine Intolerance to gemcitabine Disease recurrence within 12 months following adjuvant gemcitabine

3.1.4 Age >= 18

3.1.5 ECOG performance status 0-2

3.1.6 Laboratory values <= 2 weeks prior to enrollment:

  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (>= 1500/mm^3)
  • Platelets (Plt) >= 100,000/mm^3
  • Hemoglobin (Hgb) >= 9 g/dL
  • Serum creatinine <= 1.5 x ULN
  • Serum bilirubin <= 1.5 x ULN (<= 3.0 x ULN if liver metastases present)
  • Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) <= 3.0 x ULN. (<= 5.0 x ULN if liver metastases present). ERCP or percutaneous stenting may be used to normalize the liver function tests

3.1.7 Echocardiogram or MUGA scan demonstrating LVEF >= 50% within 4 weeks of trial entry

3.1.8 Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

3.2 Disease-Specific Exclusion Criteria

3.2.1 Prior therapy with EGFR-targeted agents

3.2.2 If history of other primary cancer, subject will be eligible only if she or he has:

  • Curatively resected non-melanomatous skin cancer
  • Curatively treated cervical carcinoma in situ
  • Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years

3.3 General Medical Exclusion Criteria

3.3.1 Subjects known to have chronic or active hepatitis B or C infection with impaired hepatic function (ineligible if AST and ALT > 3.0 x ULN).

3.3.2 History of any medical or psychiatric condition 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

3.3.3 Male subject who is not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of study agents

3.3.4 Female subject (of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized, or not abstinent) who is not willing to use an oral, patch or implanted contraceptive, double-barrier birth control, or an IUD during the course of the study and for 6 months following the last dose of second-line treatment

3.3.5 Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to enrollment

3.3.6 Any of the following concurrent severe and/or uncontrolled medical conditions within 24 weeks of enrollment which could compromise participation in the study:

  • Unstable angina pectoris
  • Symptomatic congestive heart failure
  • Myocardial infarction <= 6 months prior to registration and/or randomization
  • Serious uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes
  • Active or uncontrolled infection
  • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • Chronic renal disease

3.3.7 Patients unwilling to or unable to comply with the protocol

3.3.8 Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech/Roche sponsored cancer study

  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 identifier: NCT01108458

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
George Albert Fisher
Genentech, Inc.
Principal Investigator: George Albert Fisher M.D. Ph.D. Stanford University
  More Information

Responsible Party: George Albert Fisher, Associate Professor of Medicine, Stanford University Identifier: NCT01108458     History of Changes
Other Study ID Numbers: PANC0010  SU-03082010-5163  18227 
Study First Received: April 20, 2010
Last Updated: November 6, 2012

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on February 17, 2017