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

Sponsor:	MediGene
Information provided by:	MediGene
ClinicalTrials.gov Identifier:	NCT00377936

Purpose

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

Condition	Intervention	Phase
Adenocarcinoma Metastasis Pancreas Neoplasms	Drug: Gemcitabine alone Drug: EndoTAG-1 and Gemcitabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Pancrelipase Gemcitabine Gemcitabine hydrochloride Ultrase

U.S. FDA Resources

Further study details as provided by MediGene:

Primary Outcome Measures:

Progression free survival [ Time Frame: Median ] [ Designated as safety issue: No ]
6-month-survival-rate [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Median ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence and percentage of patients with Adverse Events [ Time Frame: 28 days after last patient out ] [ Designated as safety issue: Yes ]
Number of clinically significant abnormal laboratory values [ Time Frame: Last patient out ] [ Designated as safety issue: Yes ]

Enrollment:	212
Study Start Date:	September 2005
Study Completion Date:	October 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Gemcitabine	Drug: Gemcitabine alone Gemcitabine monotherapy 1000 mg/m2 weekly
2: Experimental EndoTag-1 + Gemcitabine	Drug: EndoTAG-1 and Gemcitabine EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
3: Experimental EndoTag-1 + Gemcitabine	Drug: EndoTAG-1 and Gemcitabine EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
4: Experimental EndoTag-1 + Gemcitabine	Drug: EndoTAG-1 and Gemcitabine EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377936

Locations

Czech Republic

Prague, Czech Republic
Hungary

Budapest, Hungary
Ukraine

Kiev, Ukraine

Sponsors and Collaborators

MediGene

Investigators

Principal Investigator:

Matthias Löhr, Prof.

Universitätsklinikum Mannheim

More Information

No publications provided

Responsible Party:	MediGene ( Susanne Kienzle-Horn / Clinical Trial Manager )
Study ID Numbers:	CT4001, EudraCT No.: 2005-000666-39
Study First Received:	September 18, 2006
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00377936 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by MediGene:

Adenocarcinoma of the pancreas
Locally advanced
Metastatic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Pancrelipase
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Gemcitabine

Endocrine Gland Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Gastrointestinal Agents
Endocrine System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on February 08, 2010