Inoperable locally advanced pancreatic cancer. MedDRA version: 12.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable
Conditions
Interventions
Trade Name: Vectibix
Pharmaceutical Form: Intravenous infusion
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological or cytological confirmed pancreatic cancer. 2. Not eligible for curative resection. 3. No distant metastases present. 4. Previously untreated with chemotherapy and anti-cancer biologicals for current malignancy. 5. No other current malignant disease, except for basal cell carcinoma of the skin. 6. Measurable or evaluable disease as defined by RECIST 1.1 criteria. 7. Performance status 0–2 Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scale. 8. Age = 18 years. 9. Adequate haematological and biological functions: • Bone marrow function: a. Neutrophils = 1.5 x 109/L b. Platelets = 100 x 109/L c. Hb = 6 mmol/L • Hepatic function: a. AST/ALT and alkaline phosphatase (ALP) = 2.5 x institutional upper limit of normal (ULN) b. Bilirubin = 1.5 times institutional ULN • Renal function: eGFR >50ml/min • Metabolic Function: a. Magnesium = lower limit of normal b. Calcium = lower limit of normal. 10. No imminent bowel obstruction. 11. No active bleeding. 12. No uncontrolled infection. 13. Patients with reproductive potential must use effective contraception. Female patients must have a negative pregnancy test. 14. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participation in another therapeutic clinical study within 30 days of enrollment or during this clinical study. 2. No adequate radiation therapy possible: based on the opinion of the radiation oncologist when radiation therapy cannot be performed because radiation field is too large (PTV volume too large or OAR too high) 3. History of allergic reactions to gemcitabine or antibody treatment. 4. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection, uncontrolled hypertension). 5. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 1 year before enrolment/randomization 6. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. 7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance. 8. Pregnant or breastfeeding women. 9. Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment. 10. Known positive status for HIV and/or hepatitis B or C. 11. Any reason why, in the investigator’s opinion, the patient should not participate in the study. 12. Drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I part To determine the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer. Phase II part 1) To investigate the proportion of patients with inoperable locally advanced pancreatic cancer receiving chemoradiation with gemcitabine plus panitumumab as first line treatment, that is progression-free at 7 months. 2) To evaluate the safety and tolerability for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer. ;Secondary Objective: 1) To assess early signs of clinical activity of the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer. 2) To assess the clinical response rate of the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer. 3) To assess time-to-progression (TTP) and overall survival amongst patients with inoperable locally advanced pancreatic cancer receiving chemoradiation with gemcitabine plus panitumumab as first line treatment. ;Primary end point(s): Phase I 1 The recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer. Phase II 1) The proportion of patients with inoperable locally advanced pancreatic cancer receiving chemoradiation with gemcitabine plus panitumumab as first line treatment, that is alive and progression-free at 7 months. 2) The safety and tolerability for the combination of chemoradiation with gemcitabine, plus panitumumab in patients with inoperable locally advanced pancreatic cancer. | — |
Countries
Netherlands
Outcome results
None listed