GEMOX: Oxaliplatin in Pancreatic Cancer

NCT00261092 | Completed Phase 2

• 1 other identifier: PM_L_0126
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall response rate based on RECIST criteria

Secondary Outcomes (4)

• Time to progression

• Overall survival

• Clinical benefit

• Quality of life

Interventions

Oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Seoul, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Won-Sik Lee, MD

  sanofi-avents

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 1, 2005
• First Posted: December 2, 2005
• Study Start: October 1, 2005
• Last Updated: April 15, 2008

Record last verified: 2008-04

Locations

KR (1)