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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2005-000666-39-DE |
Date of registration:
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07/10/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Controlled, Randomized, Open label Phase II Trial to Evaluate Safety and Efficacy of a 1st line Combination Treatment with Weekly Infusion 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 - N/A
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Scientific title:
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A Controlled, Randomized, Open label Phase II Trial to Evaluate Safety and Efficacy of a 1st line Combination Treatment with Weekly Infusion 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 - N/A |
Date of first enrolment:
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03/08/2005 |
Target sample size:
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200 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000666-39 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Czech Republic
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Germany
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Hungary
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Sweden
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion Criteria: - Written informed consent - Histologically or cytologically confirmed, pancreatic adenocarcinoma suitable for chemotherapy - Clinical diagnosis of irresectable pancreatic adenocarcinoma ECOG Performance Status 0, 1 or 2 - = 18 years old - Negative pregnancy test (females of childbearing potential) - Willingness to perform double-barrier contraception during study and for 6 months post chemotherapy treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: - Cardiovascular disease, New York Heart Association (NYHA) III or IV - History of severe supraventricular or ventricular arrhythmia - History of coagulation or bleeding disorder (PTT > 1.5 x ULN) - Severe pulmonary obstructive or restrictive disease - Diabetic retinopathy - Acute or chronic inflammation (autoimmune or infectious) - Significant active/unstable non-malignant disease likely to interfere with study assessments - Laboratory tests (hematology, chemistry) outside specified limits: - WBC = 3 x 1000/ mm3 - ANC = 1.5 x 1000/mm3 - Platelets = 100.000 / mm3 - Hb = 9.0 g/dl (= 5.6 mmol/l) - PT/PTT > 1.5 x ULN - Serum creatinine > 2.0 mg/dl (> 176.8 mmol/l) - AST and/or ALT > 5 x ULN - Alkaline phosphatase > 2 x ULN - Total bilirubin > 2 x ULN - Immunotherapy < 6 weeks prior to enrollment - Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment - Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field - Major surgery < 4 weeks prior to enrollment - Pregnant or nursing - Investigational medicinal product < 4 weeks of enrollment - HIV history - Hypersensitivity to any component of the EndoTAG™-1 and/or gemcitabine formulations - History of significant liver pathology (other than metastases) - History of malignancy other than pancreatic cancer < 5 years prior to enrollment, except skin cancer treated locally - Vulnerable populations (e.g. subjects incapable of giving consent personally)
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas MedDRA version: 8.1
Level: LLT
Classification code 10052747
Term: Adenocarcinoma pancreas
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Intervention(s)
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Product Name: EndoTAG-1 Product Code: EndoTAG-1 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Paclitaxel CAS Number: 33069-62-4 Current Sponsor code: MDG.09.100 Other descriptive name: Semi-synthetic Paclitaxel Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6.4 -
Trade Name: Gemzar Product Name: Gemcitabine Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Gemcitabine CAS Number: 122111-03-9 Current Sponsor code: Gemcitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
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Primary Outcome(s)
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Secondary Objective: none
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Primary end point(s): Efficacy Endpoints
· Median progression free survival (PFS) · 6-month-survival-rate calculated by the rate of patients alive 6 months after start of treatment · Median overall survival (OS) · Tumor Response (CR / PR / SD / PD) after 14 applications of EndoTAG™-1 and 7 applications of gemcitabine (1 cycle) assessed by the following variables: CT/MRI scans, chest X-ray and CA19-9 level kinetics · Clinical Benefit via Assessment of Quality of Life (QoL): EORTC-QoL-C30-Questionnaire + PAN-26-module · Pain assessment (Visual analogue scale = VAS) · ECOG: Number of patients with improvement/ steady state/ deterioration at week 8 compared to baseline · CA 19-9: Number of subjects with increase/no change/decrease between baseline and end of treatment, number of subjects within the normal range at baseline and at end of treatment
Safety endpoints · Adverse Events: Incidence and percentage of patients with treatment emergent AEs · Laboratory Values: Number of clinically significant abnormal laboratory values · Dose variations: Percentage of patients having dose reductions/ pausing or discontinuations of gemcitabine and/or EndoTAG™-1
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Main Objective: Safety Objectives:
· Assessment of the safety of biweekly infusions of EndoTAG™-1 and weekly infusions of gemcitabine via: · Incidence and percentage with patients EndoTAG™-1 and gemcitabine related AE · Laboratory abnormalities (hematology, coagulation parameters, clinical chemistry, urine analysis) · Dose reductions, pausing and/or discontinuations of EndoTAG™-1 and/or gemcitabine
Efficacy Objectives:
· Assessment of survival (progression free survival, 6-month survival rate, overall survival) · Tumor response evaluation after 14 applications of EndoTAG™-1 and 7 applications of gemcitabine, i.e. 1 week after last treatment and according to follow-up plan · Clinical Benefit Assessment via Quality of Life (QoL) Scale (EORTC-QoL-C30-Questionnaire, PAN-26-module) · Assessment of clinical status via ECOG Scale
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Secondary ID(s)
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CT 4001
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N/A
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Source(s) of Monetary Support
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Results
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Results available:
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