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Anti-metabolite
Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer
Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial
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.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Survival (PFS)
Secondary study objectives
Disease Controlled Rate (DCR)
Duration of response
Median Overall Survival (OS)
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: XELOX or modified FOLFOX-6Experimental Treatment3 Interventions
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.
Group II: 5-FU & LVActive Control2 Interventions
* 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Oxaliplatin
FDA approved
Leucovorin
FDA approved
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,215 Previous Clinical Trials
4,047,022 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,021,554 Total Patients Enrolled