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

• ClinicalTrials.gov Identifier: NCT01108458
• Recruitment Status: Terminated
• First Posted: April 22, 2010
• Results First Posted: March 3, 2017
• Last Update Posted: March 3, 2017
• Sponsor: George Albert Fisher
• Collaborator: Genentech, Inc.
• Information provided by (Responsible Party): George Albert Fisher, Stanford University

Tracking Information

• First Submitted Date: April 20, 2010
• First Posted Date: April 22, 2010
• Results First Submitted Date: January 12, 2017
• Results First Posted Date: March 3, 2017
• Last Update Posted Date: March 3, 2017
• Study Start Date: July 2010
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 12, 2017): Overall Response Rate by RECIST Criteria [ Time Frame: CT imaging every 9 weeks while on protocol ]

Original Primary Outcome Measures (submitted: April 21, 2010)

• 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 ]

• Change History: Complete list of historical versions of study NCT01108458 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: January 12, 2017)

• 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.
• Overall Survival (OS) [ Time Frame: 1 year ]
• Quality of Life (QoL) [ Time Frame: 3 weeks ]
  Quality of life as assessed by EORTC QLQ-C30 questionnaire
• No. of Events of Drug-related Toxicity [ Time Frame: 3 weeks ]
  Number of incidences of serious and non-serious drug-related adverse events
• 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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma
• Official Title: A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma
• Brief Summary: A phase 2 study combining pertuzumab with erlotinib for patients with gemcitabine refractory pancreatic adenocarcinoma
• 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
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Cancer

Intervention

• Drug: Pertuzumab
  iv, 840 mg, 420 mg
  Other Names:

  • 2C4
  • Omnitarg
• Drug: Erlotinib
  PO, 150 mg
  Other Names:

  • Erlotinib hydrochloride
  • Tarceva

Study Arms

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

Interventions:

• Drug: Pertuzumab
• Drug: Erlotinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 21, 2011): 1
• Original Estimated Enrollment (submitted: April 21, 2010): 25
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01108458
• Other Study ID Numbers: IRB-18227; SU-03082010-5163 ( Other Identifier: Stanford University ); PANC0010 ( Other Identifier: OnCore )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: George Albert Fisher, Stanford University
• Study Sponsor: George Albert Fisher
• Collaborators: Genentech, Inc.

Investigators

• Principal Investigator: George Albert Fisher M.D. Ph.D.; Stanford University

• PRS Account: Stanford University
• Verification Date: January 2017