Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

• Status: Completed
• Trial end date: 2002-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Advances Inc.
• Treatments: Antibodies; Gastrins; Immunoglobulins

Criteria

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.