A phase 2 study combining pertuzumab with erlotinib for patients with gemcitabine refractory pancreatic adenocarcinoma
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
iv, 840 mg, 420 mg
PO, 150 mg
Stanford University School of Medicine
Stanford, California, United States
Overall Response Rate by RECIST Criteria
Time frame: CT imaging every 9 weeks while on protocol
Progression-free Survival (PFS)
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.
Time frame: 9 weeks
Overall Survival (OS)
Time frame: 1 year
Quality of Life (QoL)
Quality of life as assessed by EORTC QLQ-C30 questionnaire
Time frame: 3 weeks
No. of Events of Drug-related Toxicity
Number of incidences of serious and non-serious drug-related adverse events
Time frame: 3 weeks
Proportion of Participants With 50% Decrease in Tumor Marker
Change in tumor marker CA19-9, assessed as a 50% decrease from baseline
Time frame: 3 weeks
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