NCT01121848

Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

A Randomized Phase III Study of 5-Fluorouracil-based Regimen With or Without Oxaliplatin as 2nd Line Treatment of Advanced or Metastatic Pancreatic Cancer in Patients Who Have Previously Received Gemcitabine-based Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death Secondary Objective: To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	Leucovorin	Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen:
DRUG	OXALIPLATIN	Pharmaceutical form: Lyophilized powder for injection (50 mg/vial or 100 mg/vial) or aqueous solution (50 mg/10 mL and 100 mg/20 mL) Route of administration: IV Dose regimen:
DRUG	5-Fluorouracil	Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2010-05-12
• Last updated: 2014-10-27

Locations

15 sites across 1 country: Canada