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

An Open, Multiple Dose, Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Jaundice
• Intervention / Treatment: Drug: G17DT

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Jaundiced patients with bilirubin value >80 μmol/L. Received G17DT immediately prior to biliary stenting.	Drug: G17DT; Other Names: Polyclonal Antibody Stimulator (PAS)
Active Comparator: Group B; Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was <40 μmol/L.	Drug: G17DT; Other Names: Polyclonal Antibody Stimulator (PAS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamic	Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.	Weeks 0, 1,3,4,6,8,12, 16+
Patient Survival	The vital status of patients was monitored throughout the study and was followed until death or the end of the study.	Up to week 139

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection Tolerability	Tolerability was assessed by injection site during first 16 weeks after the first injection.	Up to Week 16

Collaborators and Investigators

• Sponsor: Cancer Advances Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 1999
• Primary Completion (Actual): April 1, 2002
• Study Completion: May 1, 2002

Study Registration Dates

• First Submitted: March 25, 2014
• First Submitted That Met QC Criteria: March 25, 2014
• First Posted (Estimate): March 27, 2014

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Skin Manifestations; Pancreatic Diseases; Hyperbilirubinemia; Pancreatic Neoplasms; Jaundice
• Other Study ID Numbers: PC2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No