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

Sponsor

MediGene (Industry)

Overall Status

Completed

CT.gov ID

NCT00377936

Collaborator

(none)

212

Enrollment

Locations

Arms

Duration (Months)

70.7

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma Metastasis Pancreas Neoplasms	Drug: Gemcitabine alone Drug: EndoTAG-1 and Gemcitabine Drug: EndoTAG-1 and Gemcitabine Drug: EndoTAG-1 and Gemcitabine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

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
Experimental: 3 EndoTag-1 + Gemcitabine	Drug: EndoTAG-1 and Gemcitabine EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
Experimental: 4 EndoTag-1 + Gemcitabine	Drug: EndoTAG-1 and Gemcitabine EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Outcome Measures

Primary Outcome Measures

Progression free survival [Median]
6-month-survival-rate [6 Months]
Overall survival [Median]

Secondary Outcome Measures

Incidence and percentage of patients with Adverse Events [28 days after last patient out]
Number of clinically significant abnormal laboratory values [Last patient out]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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