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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

- Written informed consent
- histologically 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 > 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 103/ mm3
- ANC = 1.5 x 103/mm3
- Platelets = 100.000 / mm3
- Hb = 9.0 g/dl (= 5.6 mmol/l)
- PT/PTT > 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials