In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
1000 µg/m\^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.
Survival
Survival in days measured starting at Baseline
Time frame: Baseline (Week 0) up to Week 52 or death.
Tumor Response
The proportion of patients having an objective tumor response using Computed Tomography (CT) and the Response Evaluation Criteria In Solid Tumors (RECIST). (RECIST) guidelines
Time frame: Weeks 0, 12, 24, 36 and 52
Quality of Life
Quality of life measured using Cancer Quality of Life Questionnaire EORTC-QLQC30 questionnaire
Time frame: Weeks 0, 6, 12, 24, 36 and 52
Quality of Life
Quality of life measured using and the EORTC QLQ-PAN26 questionnaire
Time frame: Weeks 0, 6, 12, 24, 36 and 52
Karnofsky Performance Status
Functional impairment assessment using the Karnofsky Performance Scale Index
Time frame: Week 0 to Week 52
Gastrin-17 Antibodies
Antibody assessment to determine serum levels of Gastrin -17 antibodies
Time frame: Weeks 0, 6, 12, 24, 36 and 52
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