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Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study

Phase 1/Phase 2
18 Years
Not Enrolling
Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer

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Trial Information

Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study

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

Inclusion Criteria:

- 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

Exclusion Criteria:

- Prior chemotherapy for pancreatic cancer

- Prior adjuvant radio- or radiochemotherapy for pancreatic cancer within 12 months of

- Known CNS metastases at the time of enrollment

- Neutrophil count ≤ 1.5 x109/l, platelet count ≤100 x109/l, hemoglobin ≤ 10g/dl

- Serum creatinine > 1.25 x ULN

- 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

- 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

- Psychiatric disability thought to be clinically significant in the opinion of the
investigator precluding informed consent or interfering with compliance

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Viviane Hess, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Basel, Switzerland


Switzerland: Swissmedic

Study ID:

EK-Nr. 92/05



Start Date:

October 2005

Completion Date:

December 2009

Related Keywords:

  • Locally Advanced Pancreatic Cancer
  • Metastatic Pancreatic Cancer
  • advanced pancreatic cancer
  • palliative chemotherapy
  • first-line therapy
  • capecitabine
  • oxaliplatin
  • gemcitabine
  • dose-finding study
  • Phase II
  • Pancreatic Neoplasms