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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01108458
• Other study ID #: PANC0010
• Secondary ID: SU-03082010-5163
• Status: Terminated
• Phase: Phase 2
• First received: April 20, 2010
• Last updated: November 6, 2012
• Start date: July 2010
• Est. completion date: March 2011

Study information

• Verified date: October 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Pertuzumab
iv, 840 mg, 420 mg
• Erlotinib
PO, 150 mg

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
George Albert Fisher	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate by RECIST criteria		CT imaging every 9 weeks while on protocol	No
Primary	Progression-free survival by RECIST criteria		CT imaging every 9 weeks while on protocol	No
Primary	Overall survival		1 year	No
Primary	Quality of life assessment by EORTC QLQ-C30 questionnaire		questionnaire every 3 weeks with study visit while on protocol	No
Primary	Toxicities assessed by CTCAE grading criteria v3.0		assessment every 3 weeks with study visit while on protocol	Yes
Primary	50% decrease in CA19-9 from baseline		blood draw every 3 weeks while in protocol	No