Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Clinical summary
Summary
This is a non-randomised trial and treatment allocation is not concealed. Patients will be screened and recruited into a treatment or an observation arm. In the observation arm of the study, two KRAS mutant patients undergoing alternative/standard second line chemotherapy will be enrolled for every one patient enrolled into the treatment arm. Following the enrolment of a patient in the treatment arm, the next two KRAS mutant patients who are both eligible and give consent will be selected for entry into the observation arm.
Conditions
This trial is treating people with pancreatic ductal adenocarcinoma
Eligibility
Inclusion
i. Adults, age 18 years or over, male or female
ii. Locally advanced (unresectable), recurrent or metastatic biopsy-proven PDAC (note: patients with ampullary and peri-ampullary tumours will also be allowed, providing they meet all other inclusion criteria)
iii. KRAS wild-type PDAC (for panitumumab treatment arm)
iv. ECOG performance status 0-2
v. Measurable disease as per the response evaluation criteria in RECIST guideline version 1.1
vi. Progressive disease following first line chemotherapy - defined as an increase in CA 19.9 of 30% above that recorded at the end of first line therapy (confirmed on 2 blood draws) or evidence of progressive disease on standard imaging using CT scans.
vii. Patients whose tumours recur within 12 months of the completion of adjuvant chemotherapy and are otherwise eligible for this study will be considered to have received “first line chemotherapy” for the purposes of this study. Patients who have received more than one line of chemotherapy may be considered on an individual basis, if they meet all other eligibility criteria.
viii. Adequate bone marrow function; (ANC more than or equal to 1500/mcL, platelets more than or equal to 100 000/mcL, haemoglobin more than or equal to 9g/dL)
ix. Adequate renal function; calculated creatinine clearance (CrCl) greater than or equal to 50ml/min (Cockcroft-Gault formula) or Creatinine less than or equal to 1.5 XULN
x. Adequate hepatic function; serum total bilirubin less than or equal to 1.5 times ULN, ALT/AST less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN with documented liver metastases), ALP less than or equal to 5 times ULN, and INR less than or equal to 1.5
xi. Provision of informed consent for participation in the study
Exclusion
i. Pancreatic neuroendocrine tumours, cholangiocarcinoma affecting the supra-pancreatic bile duct and tumours metastatic to the pancreas (e.g. renal cell carcinoma)
ii. Children, persons younger than 18 years of age
iii. Pregnancy or lactation
iv. Active or uncontrolled infection
v. Previous treatment with EGFR inhibitor
vi. Previous radiotherapy to the pancreas if this is the only site of measurable disease (unless there is demonstrated, clear evidence of radiological progression at the site since the completion of radiotherapy).
vii. Hypersensitivity to study drug
viii. Previous or current interstitial lung disease
ix. Previous or current pulmonary fibrosis
x. History of another malignancy within 2 years prior to allocation. (NB. Patients with adequately treated carcinoma in-situ, curatively treated uterine cervix carcinoma in-situ or non-melanoma skin carcinoma, or superficial transitional cell carcinoma of the bladder remain eligible even if diagnosed less than 2 years earlier. Patients with a history of other malignancy are eligible if they have been continuously disease-free for at least 2 years following definitive treatment.)
xi. Any severe or uncontrolled medical conditions within 3 months prior to allocation, including but not limited to:
Unstable cardiac disease, myocardial infarction or uncontrolled arrhythmia
Cirrhosis, active or chronic Hepatitis B infection, Hepatitis C infection, HIV seropositivity
Active bleeding diathesis
Renal failure
Unstable diabetes
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
AMGEN,Monash Health
Scientific Title
Efficacy of Epidermal Growth Factor Receptor (EGFR) inhibitor Panitumumab for the treatment of KRAS wild-type unresectable or metastatic pancreatic ductal adenocarcinoma
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