|- candidate number||8281|
|- NTR Number||NTR2441|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-aug-2010|
|- Secondary IDs||2010/45 METC VUmc|
|- Public Title||Gemcitabine en radiotherapie in combinatie met panitumumab bij patiŽnten met niet uitgezaaide, inoperabele alvleesklierkanker. |
|- Scientific Title||Chemoradiation with gemcitabine in combination with panitumumab for patients with locally advanced pancreatic cancer. A phase I/II study. |
|- ACRONYM||Vectibix 20080686|
|- hypothesis||The addition of panitumumab to radiotherapy plus gemcitabine will increase the number of patients who are alive and progression free at 7 months. |
|- Healt Condition(s) or Problem(s) studied||Pancreatic cancer|
|- 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 0Ė2 Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scale;
8. Age ≥ 18 years;
9. Adequate haematological and biological functions:
A. Bone marrow function:
i. Neutrophils ≥ 1.5 x 109/L;
ii. Platelets ≥ 100 x 109/L;
iii. Hb ≥ 6 mmol/L.
B. Hepatic function:
i. AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN);
ii. Bilirubin ≤ 1.5 times institutional ULN.
C. Renal function:
i. eGFR >50ml/min.
D. Metabolic Function:
i. Magnesium ≥ lower limit of normal;
ii. 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.
|- 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 patientís 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 investigatorís opinion, the patient should not participate in the study;
12. Drug or alcohol abuse.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||14-jul-2010|
|- planned closingdate||1-apr-2013|
|- Target number of participants||63|
|- Interventions||Addition of panitumumab to radiotherapy plus gemcitabine.|
|- Primary outcome||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 outcome||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.
|- Timepoints||During the first 6 weeks panitumumab will be administered weekly in combination with radiotherapy plus gemcitabine. From week 8 and further gemcitabine will be administered as monotherapy until disease progression or unacceptable toxicity. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. H.M.W. Verheul|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. H.M.W. Verheul|
|- Sponsor/Initiator ||VU University Medical Center, Department of Medical Oncology|
(Source(s) of Monetary or Material Support)
|- Brief summary||This is a phase I/II, multi-center dose escalation study.
Patients will be enrolled in cohorts of 3 per dose level until the MTD of panitumumab has been established.
Up to approximately 56 patients will be treated at the MTD level of panitumumab as established in the phase I part of the study.
Based on the historic data of patients with pancreatic cancer treated with gemcitabine based chemoradiation, we aim to increase the number of patients who are alive and progression free at 7 months from the historical value of 50% to 70% with the combination treatment of chemoradiation plus panitumumab.
|- Main changes (audit trail)|
|- RECORD||2-aug-2010 - 14-aug-2010|