Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma

NCT ID: NCT00044031

Last Updated: 2014-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2007-10-31

Brief Summary

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This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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B

Placebo (immunogen vehicle) combined with gemcitabine.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

A

500 µg G17DT immunogen combined with gemcitabine.

Group Type EXPERIMENTAL

G17DT Immunogen

Intervention Type BIOLOGICAL

Interventions

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G17DT Immunogen

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection
* Life expectancy of at least 3 months
* Functional status by Karnofsky Index of at least 70

Exclusion Criteria

* Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy
* Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
* Immunodeficiency
* Bone marrow transplant within past year
* Brain metastasis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Advances Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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R Hawkins, M.D.

Role: PRINCIPAL_INVESTIGATOR

Christie Hospital, Manchester

Other Identifiers

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PC4

Identifier Type: -

Identifier Source: org_study_id

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