Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer (PC6)

A Prospective, Randomized, Double-blind, Placebo-controlled, Group Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer.

Compare the effect of G17DT with that of placebo on the survival of subjects with advanced pancreatic cancer.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Biological: G17DT

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., Stage II, III, or IV disease)
• Male or female subjects over 18 years of age
• Subjects with a life expectancy of at least 2 months
• KPS score of ≥60%
• Written informed consent

Exclusion Criteria:

• Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy
• Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic [i.e., oral or injected] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.)
• History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix
• Known immunodeficiency
• Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.)
• Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study
• Previous G17DT treatment

• Hematological indicators as follows:

  • Hemoglobin <9.5 g/dL
  • Neutrophils <2.0 × 109/L
  • Platelets <100 × 109/L

• Any other condition or circumstance that might have the following results:

  • Worsen if the subject participated in the study
  • Reduce the subject's ability to comply with the protocol
  • Confound the interpretation of the study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G17DT; 250 µg administered at Weeks 0,1,3 and 24 by intramuscular injection, followed by additional injections (boosters) of 250 µg every 6 months at investigator's discretion.	Biological: G17DT
Placebo Comparator: Placebo; Placebo administered at Weeks 0, 1, 3, and 24 by intramuscular injection followed by additonal injections of placebo every 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Survival	The vital status of each patient was followed until death or end of the study.	Up to week 134
Number of Participants with Serious and Non-Serious Adverse Events	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.	up to week 134

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective tumor response	Patients were monitored for an objective tumor response measured by means of an abdomincal computed tomography.	Weeks 24 and 52

Collaborators and Investigators

• Sponsor: Cancer Advances Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2001
• Primary Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 17, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PC6