Randomized Study With Oxaliplatin in 2nd Line Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically proven pancreatic carcinoma

Measurable locally advanced or metastatic disease

Patient previously treated with 5-FU as a "radiation sensitizer" and all toxicities must have been resolved

+7 more

Participant Groups

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.

5-Fluorouracil is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as 5-FU for: