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

NCT01108458 | Terminated Phase 2 Results DMC

• 3 other identifiers: IRB-18227SU-03082010-5163PANC0010
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate by RECIST Criteria

  CT imaging every 9 weeks while on protocol

Secondary Outcomes (5)

• Progression-free Survival (PFS)

  9 weeks

• Overall Survival (OS)

  1 year

• Quality of Life (QoL)

  3 weeks

• No. of Events of Drug-related Toxicity

  3 weeks

• Proportion of Participants With 50% Decrease in Tumor Marker

  3 weeks

Study Arms (1)

Pertuzumab plus Erlotinib Hydrochloride

EXPERIMENTAL

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; Drug: Erlotinib

Interventions

Pertuzumab DRUG

iv, 840 mg, 420 mg

Also known as: 2C4, Omnitarg

Pertuzumab plus Erlotinib Hydrochloride

Erlotinib DRUG

PO, 150 mg

Also known as: Erlotinib hydrochloride, Tarceva

Pertuzumab plus Erlotinib Hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed pancreatic adenocarcinoma
• 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
• Prior therapy (1 or more):
• Disease progression following therapy with gemcitabine
• Intolerance to gemcitabine
• Disease recurrence within 12 months following adjuvant gemcitabine
• Age \>= 18
• ECOG performance status 0-2
• 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

You may not qualify if:

• Prior therapy with EGFR-targeted agents
• 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
• 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).
• 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
• 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
• 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
• Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to enrollment
• 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

Sponsors & Collaborators

• George Albert Fisher: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

pertuzumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: George Albert Fisher, MD
• Organization: Stanford University Medical Center

georgeaf@stanford.edu

650-725-9057

Study Officials

• George Albert Fisher M.D. Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 22, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 3, 2017
• Results First Posted: March 3, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)