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
18 Years
N/A
Both
Adenocarcinoma, Metastasis, Pancreas Neoplasms
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
Median
Safety Issue:
No
Principal Investigator
Matthias Löhr, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universitätsklinikum Mannheim
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CT4001
NCT ID:
NCT00377936
Start Date:
September 2005
Completion Date:
October 2008
Related Keywords:
- Adenocarcinoma
- Metastasis
- Pancreas Neoplasms
- Adenocarcinoma of the pancreas
- Locally advanced
- Metastatic
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Neoplasms
- Neoplasm Metastasis
- Pancreatic Neoplasms
Name | Location |
|---|
