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

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

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Pertuzumab; Drug: Erlotinib

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Tarceva; Erlotinib hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Response Rate by RECIST Criteria	CT imaging every 9 weeks while on protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)		1 year
Progression-free Survival (PFS)	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.	9 weeks
Quality of Life (QoL)	Quality of life as assessed by EORTC QLQ-C30 questionnaire	3 weeks
No. of Events of Drug-related Toxicity	Number of incidences of serious and non-serious drug-related adverse events	3 weeks
Proportion of Participants With 50% Decrease in Tumor Marker	Change in tumor marker CA19-9, assessed as a 50% decrease from baseline	3 weeks

Collaborators and Investigators

• Sponsor: George Albert Fisher
• Collaborators: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: April 21, 2010
• First Posted (Estimate): April 22, 2010

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: January 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Erlotinib Hydrochloride; Pertuzumab
• Other Study ID Numbers: IRB-18227; SU-03082010-5163 (Other Identifier: Stanford University); PANC0010 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO