Jaundice, Pancreatic Cancer
Conditions
Brief summary
The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.
Detailed description
Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.
Interventions
DRUGG17DT
Sponsors
Cancer Advances Inc.
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection. * If patients were jaundiced, bilirubin had to be \>80 μmol/L. * Male or female patients over 18 years of age. * World Health Organization (WHO) performance status of 0 to 2. * Patients with a life expectancy of at least 8 weeks. * Patients must have given written informed consent.
Exclusion criteria
* Patients undergoing a potentially curative resection. * Jaundiced patients with a bilirubin value \<80 μmol/L. * Patients not considered fit for endoscopic or percutaneous biliary stenting. * Patients receiving any other anti-cancer therapy. * History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix. * Females who were pregnant, planning to become pregnant, or who were lactating. * Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study. * Previous G17DT treatment. * Haematological indicators: Haemoglobin (Hb) \<10.0 g/dL. White cell count (WCC) \<4.0×109/L. Platelets \<100×109/L.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic | Weeks 0, 1,3,4,6,8,12, 16+ | Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit. |
| Patient Survival | Up to week 139 | The vital status of patients was monitored throughout the study and was followed until death or the end of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injection Tolerability | Up to Week 16 | Tolerability was assessed by injection site during first 16 weeks after the first injection. |
Outcome results
None listed