Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

Phase 3

Completed

• Conditions: Pancreatic Neoplasms
• Interventions: Drug: Leucovorin; Drug: OXALIPLATIN; Drug: 5-Fluorouracil

• Registration Number: NCT01121848
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Study Start: 2010-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-FU & LV	Leucovorin	* Day 1: LV 400 mg/m2 (given as a 2-hour infusion) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours. * This chemotherapy regimen will be administered each two weeks.
XELOX or modified FOLFOX-6	Leucovorin	XELOX: * Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion) * This chemotherapy regimen will be administered each two weeks. OR modified FOLFOX-6: * Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion) * Day 1: LV 400 mg/m2 (given as a 2-hour infusion simultaneous to oxaliplatin) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours (Day 1 and 2) * This chemotherapy regimen will be administered each two weeks.
XELOX or modified FOLFOX-6	OXALIPLATIN	XELOX: * Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion) * This chemotherapy regimen will be administered each two weeks. OR modified FOLFOX-6: * Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion) * Day 1: LV 400 mg/m2 (given as a 2-hour infusion simultaneous to oxaliplatin) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours (Day 1 and 2) * This chemotherapy regimen will be administered each two weeks.
5-FU & LV	5-Fluorouracil	* Day 1: LV 400 mg/m2 (given as a 2-hour infusion) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours. * This chemotherapy regimen will be administered each two weeks.
XELOX or modified FOLFOX-6	5-Fluorouracil	XELOX: * Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion) * This chemotherapy regimen will be administered each two weeks. OR modified FOLFOX-6: * Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion) * Day 1: LV 400 mg/m2 (given as a 2-hour infusion simultaneous to oxaliplatin) * Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours (Day 1 and 2) * This chemotherapy regimen will be administered each two weeks.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Within the 3 months of study treatment	PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Duration of response	12 weeks	The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence, i.e. progressive disease (PD) is determined by RECIST criteria or death
Overall response rate (ORR)	12 weeks	ORR is based on RECIST criteria and is the percentage of patients with complete response (CR) or partial response (PR).
Disease Controlled Rate (DCR)	12 weeks	DCR is also based on RECIST criteria and is defined as the percentage of patients who have a CR, PR or stable disease (SD)
Median Overall Survival (OS)	2 years	Median Survival is the number of weeks at which 50% of the patients are still alive.

Trial Locations

Locations (15)

Investigational Site Number 124011; 🇨🇦 Greenfield Park, Canada

Investigational Site Number 124010; 🇨🇦 Hamilton, Canada

Investigational Site Number 124008; 🇨🇦 Sudbury, Canada

Investigational Site Number 124018; 🇨🇦 Brampton, Canada

Investigational Site Number 124004; 🇨🇦 Sherbrooke, Canada

Investigational Site Number 124007; 🇨🇦 Surrey, Canada

Investigational Site Number 124001; 🇨🇦 Vancouver, Canada

Investigational Site Number 124013; 🇨🇦 Oshawa, Canada

Investigational Site Number 124003; 🇨🇦 Toronto, Canada

Investigational Site Number 124014; 🇨🇦 Burnaby, Canada

Investigational Site Number 124006; 🇨🇦 Calgary, Canada

Investigational Site Number 124015; 🇨🇦 Abbotsford, Canada

Investigational Site Number 124-016; 🇨🇦 New Glasgow, Canada

Investigational Site Number 124012; 🇨🇦 Ottawa, Canada

Investigational Site Number 124002; 🇨🇦 Toronto, Canada