GEMOX: Oxaliplatin in Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Neoplasms

• Registration Number: NCT00261092
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-12-01
• Study First Submitted QC: 2005-12-01
• Study First Posted: 2005-12-02
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-14
• Last Update Posted: 2008-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate based on RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Time to progression
Overall survival
Clinical benefit
Quality of life

Trial Locations

Locations (1)

Sanofi-Aventis; 🇰🇷 Seoul, Korea, Republic of