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GEMOX: Oxaliplatin in Pancreatic Cancer

Primary Purpose

Pancreatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxaliplatin
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically proven adenocarcinoma of the pancreas Metastatic or locally advanced, non resectable disease(Non resectable disease will be determined by the investigators with clinical data) Uni-dimensionally measurable disease as defined by RECIST (primary or secondary tumors>2cm using conventional CT scan or ≥1cm with spiral CT scan) No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted Karnofsky Performance Status (KPS) ≥60 No known Central Nervous System metastases No sensory neuropathy at inclusion Biological and hematological evaluation < 2 weeks prior to treatment administration: Neutrophils ≥ 1500/ mm3 Platelets ≥ 100,000/mm3 Alkaline phosphatases< 5X ULN(upper Limits of Normal) and Bilirubin < 1.5X ULN SGOT,SGPT <2.5 X ULN if no liver metastasis SGOT,SGPT <5 X ULN if liver metastasis Creatinine < 1.5 X ULN Baseline imaging (CT scan or Magnetic Resonance Imaging) <3 weeks before treatment administration Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children Exclusion Criteria: Corticotherapy except for anti-emetic purpose Pregnant or breast feeding women (Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs) Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia Uncontrolled or persistent hypercalcemia History of significant neurologic or psychiatric disorders Vater ampulomas and biliary tract adenocarcinomas Other -non cured- malignancies The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

Overall response rate based on RECIST criteria

Secondary Outcome Measures

Time to progression
Overall survival
Clinical benefit
Quality of life

Full Information

First Posted
December 1, 2005
Last Updated
April 14, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00261092
Brief Title
GEMOX: Oxaliplatin in Pancreatic Cancer
Official Title
Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
Primary objective: To evaluate overall response rate (based on RECIST criterion) Secondary objective: To evaluate time to progression, clinical benefit, quality of life and safety

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Primary Outcome Measure Information:
Title
Overall response rate based on RECIST criteria
Secondary Outcome Measure Information:
Title
Time to progression
Title
Overall survival
Title
Clinical benefit
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven adenocarcinoma of the pancreas Metastatic or locally advanced, non resectable disease(Non resectable disease will be determined by the investigators with clinical data) Uni-dimensionally measurable disease as defined by RECIST (primary or secondary tumors>2cm using conventional CT scan or ≥1cm with spiral CT scan) No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted Karnofsky Performance Status (KPS) ≥60 No known Central Nervous System metastases No sensory neuropathy at inclusion Biological and hematological evaluation < 2 weeks prior to treatment administration: Neutrophils ≥ 1500/ mm3 Platelets ≥ 100,000/mm3 Alkaline phosphatases< 5X ULN(upper Limits of Normal) and Bilirubin < 1.5X ULN SGOT,SGPT <2.5 X ULN if no liver metastasis SGOT,SGPT <5 X ULN if liver metastasis Creatinine < 1.5 X ULN Baseline imaging (CT scan or Magnetic Resonance Imaging) <3 weeks before treatment administration Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children Exclusion Criteria: Corticotherapy except for anti-emetic purpose Pregnant or breast feeding women (Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs) Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia Uncontrolled or persistent hypercalcemia History of significant neurologic or psychiatric disorders Vater ampulomas and biliary tract adenocarcinomas Other -non cured- malignancies The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won-Sik Lee, MD
Organizational Affiliation
sanofi-avents
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

GEMOX: Oxaliplatin in Pancreatic Cancer

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