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

This study has been terminated.
(Extreme toxicity of Pertuzumab and Erlotinib combination)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
George Albert Fisher, Stanford University
ClinicalTrials.gov Identifier:
NCT01108458
First received: April 20, 2010
Last updated: November 6, 2012
Last verified: October 2011
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Progression-free survival by RECIST criteria [ Time Frame: CT imaging every 9 weeks while on protocol ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of life assessment by EORTC QLQ-C30 questionnaire [ Time Frame: questionnaire every 3 weeks with study visit while on protocol ] [ Designated as safety issue: No ]
  • Toxicities assessed by CTCAE grading criteria v3.0 [ Time Frame: assessment every 3 weeks with study visit while on protocol ] [ Designated as safety issue: Yes ]
  • 50% decrease in CA19-9 from baseline [ Time Frame: blood draw every 3 weeks while in protocol ] [ Designated as safety issue: No ]

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.

  Eligibility

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

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):

3.1.3.1 Disease progression following therapy with gemcitabine

3.1.3.2 Intolerance to gemcitabine

3.1.3.3 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 ClinicalTrials.gov identifier: NCT01108458

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

No publications provided

Responsible Party: George Albert Fisher, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib
Pertuzumab
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014