Locally-advanced (unresectable) pancreatic adenocarcinoma, undifferentiated carcinoma or non-small cell carcinoma. MedDRA version: 9.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable
Conditions
Interventions
Trade Name: Gemzar
Product Name: gemcitabine hydrochloride
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Xeloda
Pha
Sponsors
The Royal Marsden Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Age >18 years. b) Histological or cytological diagnosis of adeno- or undifferentiated non-small cell carcinoma of pancreas. c) Considered to be unresectable d)In patient with a histological diagnosis, paraffin embedded blocks and slides of tumour tissue should be available for centralised EGFR staining and K-ras testing. e) WHO performance status 0-2. f) No evidence of metastatic disease as determined by CT scan (chest, abdomen and pelvis) or other investigations such as PET scan or biopsy if required. g) Adequate bone marrow function with platelets =100 x 109/l; WBC =3 x 109/l; neutrophils =1.5 x 109/l. h) Serum bilirubin =1.5 × upper limit of institutional normal range (ULN) and transaminases =2.5? ULN. i) Calculated/measured glomerular filtration rate =50ml/min f) No concurrent uncontrolled medical condition. j) No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years. k) Life expectancy > 3 months. l) Adequate contraceptive precautions if relevant. m) Informed written 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: a) Medical or psychiatric conditions that compromise the patient’s ability to give informed consent. b) Presence of metastatic disease. c) Concurrent uncontrolled medical conditions. d) Any previous chemotherapy or radiotherapy, and any investigational treatment for advanced pancreatic cancer. e) Adjuvant chemotherapy with fluoropyrimidine or gemcitabine within 12 months of trial entry. f) Adjuvant radiotherapy with or without chemotherapy for pancreatic cancer g) Pregnancy or breast feeding. h) Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract. i) Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency j) Clinically significant (i.e. active) cardiovascular disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: One-year overall survival rate; Secondary Objective: (1) Progression free survival (2) Safety (3) Objective response rate (4) Pattern of failure (5) Quality of life ; Primary end point(s): The primary endpoint of this study is 1-year overall survival (OS). Based on the pooled GERCOR studies, the lower limit of 95% confidence interval for the 1-year survival rate of chemotherapy alone group would be 35%.8 An 1-year OS rate from the time of registration of =55% is considered acceptable (p1) and an 1-year OS rate from the time of registration of <35% would be ruled out as unacceptable (p0). In each arm, if =20 out of 41 patients are alive at one year, then the treatment would be considered suitable for evaluation in definitive phase III studies (2-sided alpha = 0.05, 80% power). Giving 10% drop out rate, a total of 45 patients per arm (90 patients in total) will be randomised | — |
Countries
United Kingdom
Outcome results
None listed