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Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC

NCT01290783 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2015-04-29

No results posted yet for this study

Summary

Trial design:

* Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen.
* Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve.
* Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom).
* Dosing regimen:

* Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients \> 75 years of age, the irinotecan and HA-Irinotecan dose in must be reduced to 150 mg/m2).
* Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
* 5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
* Repeat every 2 weeks for 8 months.
* Patient accrual over approximately 12-14 months.
* Monitoring to 18 months post-randomization.
* 390 patients.
* Progression Free Survival (PFS) primary endpoint.
* Safety analysis on the initial 20 patients.

Conditions

Interventions

DRUG

Irintoecan

* Irinotecan, 180 mg/m2 IV, over 90 minutes, day 1 (in patients \> 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2). * Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan. * 5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion. * Repeat every two weeks. * 8 months of treatment.

DRUG

HA-Irinotecan solution for Infusion

* HA-Irinotecan (irinotecan 180 mg/m2), IV, over 90 minutes, day 1 (in patients \> 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2). * Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan. * 5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion. * Repeat every two weeks * 8 months of treatment.

Sponsors & Collaborators

  • Alchemia Oncology

    lead INDUSTRY

Principal Investigators

  • Peter Gibbs, MD · Melbourne Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-10-31
Completion
2015-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290783 on ClinicalTrials.gov