Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospital, Basel, Switzerland
With
Swiss National Science Foundation
Swiss Cancer League
Roche Pharma AG
Sanofi
Primary Objectives:
* Phase I: to determine the maximum tolerated dose (MTD) of oxaliplatin in combination with gemcitabine and capecitabine (GEMOXEL) in patients with APC
* Phase II: to assess any anti-tumor activity of GEMOXEL in patients with APC
Secondary Objectives:
* to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC
Primary Endpoints:
* Phase I: Dose-limiting toxicity
* Phase II: Objective tumor response
Secondary Endpoints:
* Toxicity at MTD according to NCI CTC 3.0
* Progression-free survival and Overall Survival
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Cytologically or histologically confirmed adenocarcinoma of the exocrine pancreas
Disease non-resectable and locally advanced or metastatic
Measurable disease or evaluable disease i.e. tumor marker CA19-9 at baseline ≥ 1.5 x upper limit of normal (ULN)
Age \>18 years
Karnofsky performance status ≥ 60%
Life expectancy of at least 3 months
Written informed consent
Willing and able to comply with the protocol for the duration of the study
You may not be if
Prior chemotherapy for pancreatic cancer
Prior adjuvant radio- or radiochemotherapy for pancreatic cancer within 12 months of inclusion
ASAT, ALAT and alkaline phosphatase \> 2.5 ULN or \> 5 ULN in the presence of liver metastasis, Bilirubin \> 1.5 ULN (after treatment of obstructive jaundice eg. stent)
Pregnant or breast feeding women (women of childbearing potential must have a negative pregnancy test at baseline)
Men and women of reproductive potential who are not using an effective method of contraception
Clinically significant cardiac disease (NYHA III-IV) or myocardial infarction within the last 12 months
Neurological disease with dys-/paraesthesias \> grade 1 according to NCI CTC
Any serious concomitant disorder incompatible with the trial (in the judgement of the investigator)
Psychiatric disability thought to be clinically significant in the opinion of the investigator precluding informed consent or interfering with compliance
Clareo Health | Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma
