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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 Com...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-000666-39

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

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Extrait

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

Critère d'inclusion

  • Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

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