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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00377936

Enrollment

212

Registered

2006-09-19

Start date

2005-09-30

Completion date

2008-10-31

Last updated

2008-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma, Metastasis, Pancreas Neoplasms

Keywords

Adenocarcinoma of the pancreas, Locally advanced, Metastatic

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.

Interventions

DRUGGemcitabine alone

Gemcitabine monotherapy 1000 mg/m2 weekly

DRUGEndoTAG-1 and Gemcitabine

EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Progression free survival	Median
6-month-survival-rate	6 Months
Overall survival	Median

Secondary

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

Countries

Czechia, Hungary, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026