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

This study has been completed.
Sponsor:
Information provided by:
MediGene
ClinicalTrials.gov Identifier:
NCT00377936
First received: September 18, 2006
Last updated: November 13, 2008
Last verified: November 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Susanne Kienzle-Horn / Clinical Trial Manager, MediGene
ClinicalTrials.gov Identifier: NCT00377936     History of Changes
Other Study ID Numbers: CT4001, EudraCT No.: 2005-000666-39
Study First Received: September 18, 2006
Last Updated: November 13, 2008
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:
Adenocarcinoma
Neoplasms
Neoplasm Metastasis
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gemcitabine
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on July 22, 2014