Clinical trial NCT01108458: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-04-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Response Rate by RECIST Criteria
timeFrame: CT imaging every 9 weeks while on protocol
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 9 weeks
measure: Overall Survival (OS)
timeFrame: 1 year
measure: Quality of Life (QoL)
timeFrame: 3 weeks
measure: No. of Events of Drug-related Toxicity
timeFrame: 3 weeks
measure: Proportion of Participants With 50% Decrease in Tumor Marker
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: George Albert Fisher M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: