EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
This study has been completed.
Sponsor:
MediGene
Information provided by:
MediGene
ClinicalTrials.gov Identifier:
NCT00377936
First received: September 18, 2006
Last updated: November 13, 2008
Last verified: November 2008
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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 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 Adenocarcinoma, Mucinous Neoplasms Neoplasm Metastasis Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous 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 |
ClinicalTrials.gov processed this record on June 17, 2013