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

Primary Purpose

Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
gemcitabine, oxaliplatin, capecitabine
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Pancreatic Cancer focused on measuring advanced pancreatic cancer, palliative chemotherapy, first-line therapy, capecitabine, oxaliplatin, gemcitabine, dose-finding study, Phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cantonal Hospital Bruderholz
  • Cantonal Hospital Liestal
  • St. Clara Hospital
  • University Hospital Basel
  • Cantonal Hospital Lucerne
  • City Hospital Triemli
  • Oncocenter Hirslanden
  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single

Arm Description

single arm study with triple combination chemotherapy

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Progression-free survival and overall survival

Full Information

First Posted
August 29, 2008
Last Updated
January 11, 2010
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation, Swiss Cancer League, Roche Pharma AG, Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00744640
Brief Title
Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma
Acronym
GEMOXEL
Official Title
Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation, Swiss Cancer League, Roche Pharma AG, Sanofi

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer
Keywords
advanced pancreatic cancer, palliative chemotherapy, first-line therapy, capecitabine, oxaliplatin, gemcitabine, dose-finding study, Phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single
Arm Type
Experimental
Arm Description
single arm study with triple combination chemotherapy
Intervention Type
Drug
Intervention Name(s)
gemcitabine, oxaliplatin, capecitabine
Intervention Description
gemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks
Primary Outcome Measure Information:
Title
Response rate
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival and overall survival
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viviane Hess, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cantonal Hospital Bruderholz
City
Bruderholz
State/Province
BL
Country
Switzerland
Facility Name
Cantonal Hospital Liestal
City
Liestal
State/Province
BL
Country
Switzerland
Facility Name
St. Clara Hospital
City
Basel
Country
Switzerland
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Facility Name
Cantonal Hospital Lucerne
City
Lucerne
Country
Switzerland
Facility Name
City Hospital Triemli
City
Zurich
Country
Switzerland
Facility Name
Oncocenter Hirslanden
City
Zurich
Country
Switzerland
Facility Name
University Hospital
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

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Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma

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