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Trial record 30 of 188 for:    pertuzumab

A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01108458
Recruitment Status : Terminated (Extreme toxicity of Pertuzumab and Erlotinib combination)
First Posted : April 22, 2010
Results First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Genentech, Inc.
Information provided by (Responsible Party):
George Albert Fisher, Stanford University

Brief Summary:
A phase 2 study combining pertuzumab with erlotinib for patients with gemcitabine refractory pancreatic adenocarcinoma

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Pertuzumab Drug: Erlotinib Phase 2

Detailed Description:
A single-institution, single-arm phase 2 study investigating pertuzumab and erlotinib as a palliative regimen in the treatment of locally-advanced or metastatic pancreatic adenocarcinoma.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma
Study Start Date : July 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pertuzumab plus Erlotinib Hydrochloride

Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks

Erlotinib hydrochloride 150 mg/day by mouth

Drug: Pertuzumab
iv, 840 mg, 420 mg
Other Names:
  • 2C4
  • Omnitarg

Drug: Erlotinib
PO, 150 mg
Other Names:
  • Erlotinib hydrochloride
  • Tarceva

Primary Outcome Measures :
  1. Overall Response Rate by RECIST Criteria [ Time Frame: CT imaging every 9 weeks while on protocol ]

Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 9 weeks ]

    Disease status evaluated by computed tomography (CT) scan and progression-free survival assessed per RECIST criteria.

    Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported.

  2. Overall Survival (OS) [ Time Frame: 1 year ]
  3. Quality of Life (QoL) [ Time Frame: 3 weeks ]
    Quality of life as assessed by EORTC QLQ-C30 questionnaire

  4. No. of Events of Drug-related Toxicity [ Time Frame: 3 weeks ]
    Number of incidences of serious and non-serious drug-related adverse events

  5. Proportion of Participants With 50% Decrease in Tumor Marker [ Time Frame: 3 weeks ]
    Change in tumor marker CA19-9, assessed as a 50% decrease from baseline

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01108458

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

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Responsible Party: George Albert Fisher, Associate Professor of Medicine, Stanford University Identifier: NCT01108458    
Other Study ID Numbers: IRB-18227
SU-03082010-5163 ( Other Identifier: Stanford University )
PANC0010 ( Other Identifier: OnCore )
First Posted: April 22, 2010    Key Record Dates
Results First Posted: March 3, 2017
Last Update Posted: March 3, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological