GEMOX: Oxaliplatin in Pancreatic Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Oxaliplatin

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.