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

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

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

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.

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Overall response rate by RECIST criteria

Outcome Time Frame:

CT imaging every 9 weeks while on protocol

Safety Issue:


Principal Investigator

George Albert Fisher M.D. Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

March 2011

Related Keywords:

  • Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317