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

Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377936
• Other study ID #: CT4001
• Secondary ID: EudraCT No.: 200
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2006
• Last updated: November 13, 2008
• Start date: September 2005
• Est. completion date: October 2008

Study information

• Verified date: November 2008
• Source: MediGene
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: October 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastasis
• Pancreas Neoplasms
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine alone
Gemcitabine monotherapy 1000 mg/m2 weekly
• EndoTAG-1 and Gemcitabine
EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
• EndoTAG-1 and Gemcitabine
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
• EndoTAG-1 and Gemcitabine
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MediGene

Countries where clinical trial is conducted

Czech Republic,  Hungary,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		Median	No
Primary	6-month-survival-rate		6 Months	No
Primary	Overall survival		Median	No
Secondary	Incidence and percentage of patients with Adverse Events		28 days after last patient out	Yes
Secondary	Number of clinically significant abnormal laboratory values		Last patient out	Yes