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

Condition(s) targeted: Adenocarcinoma; Metastasis; Pancreas Neoplasms

Intervention: Gemcitabine alone (Drug); EndoTAG-1 and Gemcitabine (Drug); EndoTAG-1 and Gemcitabine (Drug); EndoTAG-1 and Gemcitabine (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: MediGene

Official(s) and/or principal investigator(s):
Matthias Löhr, Prof., Principal Investigator, Affiliation: Universitätsklinikum Mannheim

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

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Progression free survival

6-month-survival-rate

Overall survival

Secondary outcome:

Incidence and percentage of patients with Adverse Events

Number of clinically significant abnormal laboratory values

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Prague, Czech Republic

Budapest, Hungary

Kiev, Ukraine

Starting date: September 2005
Last updated: June 17, 2008