Pancreatic Cancer
Conditions
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.
Interventions
DRUGPertuzumab
iv, 840 mg, 420 mg
DRUGErlotinib
PO, 150 mg
Sponsors
Genentech, Inc.
George Albert Fisher
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate by RECIST Criteria | CT imaging every 9 weeks while on protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | 9 weeks | 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. |
| Overall Survival (OS) | 1 year | — |
| Quality of Life (QoL) | 3 weeks | Quality of life as assessed by EORTC QLQ-C30 questionnaire |
| No. of Events of Drug-related Toxicity | 3 weeks | Number of incidences of serious and non-serious drug-related adverse events |
| Proportion of Participants With 50% Decrease in Tumor Marker | 3 weeks | Change in tumor marker CA19-9, assessed as a 50% decrease from baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pertuzumab Plus Erlotinib Hydrochloride Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks
Erlotinib hydrochloride 150 mg/day by mouth
Pertuzumab: iv, 840 mg, 420 mg
Erlotinib: PO, 150 mg | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Pertuzumab Plus Erlotinib Hydrochloride |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Gender Female | 0 Participants |
| Gender Male | 1 Participants |
| Region of Enrollment United States | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Overall Response Rate by RECIST Criteria
Time frame: CT imaging every 9 weeks while on protocol
| Arm | Measure | Value |
|---|---|---|
| Pertuzumab Plus Erlotinib Hydrochloride | Overall Response Rate by RECIST Criteria | 0 |
Secondary
No. of Events of Drug-related Toxicity
Number of incidences of serious and non-serious drug-related adverse events
Time frame: 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pertuzumab Plus Erlotinib Hydrochloride | No. of Events of Drug-related Toxicity | 3 Drug-related adverse events |
Secondary
Overall Survival (OS)
Time frame: 1 year
| Arm | Measure | Value |
|---|---|---|
| Pertuzumab Plus Erlotinib Hydrochloride | Overall Survival (OS) | 0 |
Secondary
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
| Arm | Measure | Value |
|---|---|---|
| Pertuzumab Plus Erlotinib Hydrochloride | Progression-free Survival (PFS) | 0 |
Secondary
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
| Arm | Measure | Value |
|---|---|---|
| Pertuzumab Plus Erlotinib Hydrochloride | Proportion of Participants With 50% Decrease in Tumor Marker | 0 |
Secondary
Quality of Life (QoL)
Quality of life as assessed by EORTC QLQ-C30 questionnaire
Time frame: 3 weeks
| Arm | Measure | Value |
|---|---|---|
| Pertuzumab Plus Erlotinib Hydrochloride | Quality of Life (QoL) | 0 |