An Open Label Study to Evaluate G17DT Compared to Gemcitabine

Pancreatic Cancer Clinical Trial

Official title:

A Phase 3 Study to Evaluate the Efficacy and Safety of 250 µg G17DT or 1000 µg/m^2 Gemcitabine in Subjects With Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200821
• Other study ID #: PC3
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2017
• Last updated: June 26, 2017
• Start date: August 14, 2000
• Est. completion date: September 19, 2002

Study information

• Verified date: June 2017
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: September 19, 2002
• Est. primary completion date: September 24, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent.

• A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection.

• Male or female patients over 18 years of age.

• Laboratory values within the following ranges at screening:

Serum creatinine < 1.25 times upper limit of normal (ULN) Haemoglobin > 9.5 g/dL White blood cell (WBC) count > 3.5 x 109/L Platelets > 100 x 109/L Total bilirubin < 2.0 times ULN Aspartate transaminase (AST, SGOT) < 3 times ULN

• A life expectancy of at least 2 months.

• A negative pregnancy test at the screening visit (females of childbearing potential only).

• Signed written informed consent.

Exclusion Criteria:

• History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix).

• Previous cytotoxic chemotherapy (including gemcitabine).

• Previous radiotherapy within 30 days of baseline.

• Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted.

• Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study.

• Participation in another study involving an investigational drug within 90 days of baseline.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• G17DT
250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.

Drug:
• Gemcitabine
1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Advances Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival in days measured starting at Baseline	Baseline (Week 0) up to Week 52 or death.
Secondary	Tumor Response	The proportion of patients having an objective tumor response using Computed Tomography (CT) and the Response Evaluation Criteria In Solid Tumors (RECIST).; (RECIST) guidelines	Weeks 0, 12, 24, 36 and 52
Secondary	Quality of Life	Quality of life measured using Cancer Quality of Life Questionnaire EORTC-QLQC30 questionnaire	Weeks 0, 6, 12, 24, 36 and 52
Secondary	Quality of Life	Quality of life measured using and the EORTC QLQ-PAN26 questionnaire	Weeks 0, 6, 12, 24, 36 and 52
Secondary	Karnofsky Performance Status	Functional impairment assessment using the Karnofsky Performance Scale Index	Week 0 to Week 52
Secondary	Gastrin-17 Antibodies	Antibody assessment to determine serum levels of Gastrin -17 antibodies	Weeks 0, 6, 12, 24, 36 and 52