Pancreatic Cancer
Conditions
Brief summary
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.
Interventions
BIOLOGICALG17DT
250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
DRUGGemcitabine
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.
Sponsors
Cancer Advances Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized, open, parallel group, active comparator
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent. * A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection. * Male or female patients over 18 years of age. * Laboratory values within the following ranges at screening: Serum creatinine \< 1.25 times upper limit of normal (ULN) Haemoglobin \> 9.5 g/dL White blood cell (WBC) count \> 3.5 x 109/L Platelets \> 100 x 109/L Total bilirubin \< 2.0 times ULN Aspartate transaminase (AST, SGOT) \< 3 times ULN * A life expectancy of at least 2 months. * A negative pregnancy test at the screening visit (females of childbearing potential only). * Signed written informed consent.
Exclusion criteria
* History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix). * Previous cytotoxic chemotherapy (including gemcitabine). * Previous radiotherapy within 30 days of baseline. * Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted. * Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study. * Participation in another study involving an investigational drug within 90 days of baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Baseline (Week 0) up to Week 52 or death. | Survival in days measured starting at Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | Weeks 0, 12, 24, 36 and 52 | The proportion of patients having an objective tumor response using Computed Tomography (CT) and the Response Evaluation Criteria In Solid Tumors (RECIST). (RECIST) guidelines |
| Quality of Life | Weeks 0, 6, 12, 24, 36 and 52 | Quality of life measured using Cancer Quality of Life Questionnaire EORTC-QLQC30 questionnaire |
| Karnofsky Performance Status | Week 0 to Week 52 | Functional impairment assessment using the Karnofsky Performance Scale Index |
| Gastrin-17 Antibodies | Weeks 0, 6, 12, 24, 36 and 52 | Antibody assessment to determine serum levels of Gastrin -17 antibodies |
Outcome results
None listed