GEMOX: Oxaliplatin in Pancreatic Cancer

Pancreatic Neoplasms Clinical Trial

Official title:

Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261092
• Other study ID #: PM_L_0126
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2005
• Last updated: April 14, 2008
• Start date: October 2005

Study information

• Verified date: April 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• Oxaliplatin

Locations

Country	Name	City	State
Korea, Republic of	Sanofi-Aventis	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate based on RECIST criteria
Secondary	Time to progression
Secondary	Overall survival
Secondary	Clinical benefit
Secondary	Quality of life