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

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ClinicalTrials.gov Identifier: NCT00377936
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : November 14, 2008
Sponsor:
Information provided by:
MediGene

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 Phase 2

Study Type : Interventional  (Clinical Trial)
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 : September 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Median ]
  2. 6-month-survival-rate [ Time Frame: 6 Months ]
  3. Overall survival [ Time Frame: Median ]

Secondary Outcome Measures :
  1. Incidence and percentage of patients with Adverse Events [ Time Frame: 28 days after last patient out ]
  2. Number of clinically significant abnormal laboratory values [ Time Frame: Last patient out ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Susanne Kienzle-Horn / Clinical Trial Manager, MediGene
ClinicalTrials.gov Identifier: NCT00377936     History of Changes
Other Study ID Numbers: CT4001
EudraCT No.: 2005-000666-39
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: November 2008

Keywords provided by MediGene:
Adenocarcinoma of the pancreas
Locally advanced
Metastatic

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Pancrelipase
Pancreatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents