EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

November 13, 2008 updated by: MediGene

A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Compared With Gemcitabine Monotherapy in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Inoperable adenocarcinoma of the pancreas
  • Histologic or cytologic confirmation
  • At least 18 years of age

Exclusion Criteria:

  • Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
  • Major surgery within 4 weeks prior to enrollment
  • Major cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Gemcitabine
Drug: Gemcitabine alone
Gemcitabine monotherapy 1000 mg/m2 weekly
Experimental: 2
EndoTag-1 + Gemcitabine
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Experimental: 3
EndoTag-1 + Gemcitabine
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Experimental: 4
EndoTag-1 + Gemcitabine
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Drug: EndoTAG-1 and Gemcitabine
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Median
Median
Progression free survival
Time Frame: Median
Median
6-month-survival-rate
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and percentage of patients with Adverse Events
Time Frame: 28 days after last patient out
28 days after last patient out
Number of clinically significant abnormal laboratory values
Time Frame: Last patient out
Last patient out

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MediGene

Investigators

  • Principal Investigator: Matthias Löhr, Prof., Universitätsklinikum Mannheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 18, 2006

First Posted (Estimate)

September 19, 2006

Study Record Updates

Last Update Posted (Estimate)

November 14, 2008

Last Update Submitted That Met QC Criteria

November 13, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT4001
  • EudraCT No.: 2005-000666-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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