Pancreatic Cancer
Conditions
Brief summary
This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.
Interventions
DRUGG17DT
Sponsors
Cancer Advances Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent * Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study * Male or female patients over 18 years of age * Patients with a life expectancy of at least 2 months * Patients must have given written informed consent * Patients with a Karnofsky Performance Status score of ≥ 50% * Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)
Exclusion criteria
* History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix * Concomitant use or anticipated use in the period of the study of radiotherapy * Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study * Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids * Females who were pregnant, planning to become pregnant or lactating * Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study * Haematological indicators: Haemoglobin \<9.5g/dl White blood cell count \<3.5 x 109/l Platelets \<100 x 109/l
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic | Up to week 16 | Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Survival | Up to week 139 | The vital status was monitored throughout the study and was followed up to the death of the last patient. |
| Number of Participants with Serious and Non-Serious Adverse Events | Up to week 60 | Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit. |
Outcome results
None listed