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Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma (GEMOXEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00744640
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : January 12, 2010
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy of this triple combination.

Condition or disease Intervention/treatment Phase
Locally Advanced Pancreatic Cancer Metastatic Pancreatic Cancer Drug: gemcitabine, oxaliplatin, capecitabine Phase 1 Phase 2

Detailed Description:

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study
Study Start Date : October 2005
Primary Completion Date : February 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: single
single arm study with triple combination chemotherapy
Drug: gemcitabine, oxaliplatin, capecitabine
gemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks


Outcome Measures

Primary Outcome Measures :
  1. Response rate [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Progression-free survival and overall survival [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 inclusion
  • 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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744640


Locations
Switzerland
Cantonal Hospital Bruderholz
Bruderholz, BL, Switzerland
Cantonal Hospital Liestal
Liestal, BL, Switzerland
St. Clara Hospital
Basel, Switzerland
University Hospital Basel
Basel, Switzerland
Cantonal Hospital Lucerne
Lucerne, Switzerland
City Hospital Triemli
Zurich, Switzerland
Oncocenter Hirslanden
Zurich, Switzerland
University Hospital
Zurich, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Swiss Cancer League
Roche Pharma AG
Sanofi
Investigators
Principal Investigator: Viviane Hess, MD University Hospital, Basel, Switzerland
More Information

Responsible Party: Dr. Viviane Hess, University Hospital Basel
ClinicalTrials.gov Identifier: NCT00744640     History of Changes
Other Study ID Numbers: EK-Nr. 92/05
2005DR2296
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: January 2010

Keywords provided by University Hospital, Basel, Switzerland:
advanced pancreatic cancer
palliative chemotherapy
first-line therapy
capecitabine
oxaliplatin
gemcitabine
dose-finding study
Phase II

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs