Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC

NCT01290783 | Unknown Phase 3 DMC

• 1 other identifier: ACO-002
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 5

Brief 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

Metastatic Colorectal Cancer

Keywords

mCRC; CRC; colorectal; irinotecan; Hyaluronic acid; Hyaluronan

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Approximately 20 months

Secondary Outcomes (1)

• Safety

  After initial 20 patients receive 2 cycles, then 6 monthly thereafter.

Study Arms (2)

FOLFIRI

ACTIVE COMPARATOR

Drug: Irintoecan

FOLF(HA)iri

EXPERIMENTAL

Drug: HA-Irinotecan solution for Infusion

Interventions

Irintoecan DRUG

* 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.

FOLFIRI

HA-Irinotecan solution for Infusion DRUG

* 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.

FOLF(HA)iri

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic colorectal cancer with disease progression after first or second line chemotherapy
• Irinotecan naïve.
• ECOG performance status of 0 or 1.
• Measurable disease, i.e. at least one measurable metastatic lesion (spiral CT or MRI).
• Histological proof of colorectal cancer.
• years of age and older.
• Adequately recovered from and at least 4 weeks after recent surgery or chemotherapy.
• Women of child-bearing potential (WOCBP) and male partners of WOCBP must agree to use adequate contraception.
• Patient consent obtained and signed according to local and/or national ethics.
• CT or MRI scan of chest/abdomen/pelvis within 21 days prior to randomization.
• Hematology done within 14 days prior to randomization.
• Chemistry done within 14 days prior to randomization.

You may not qualify if:

• History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \> 5 years.
• Locally advanced or recurrent disease only.
• Unsuitability for irinotecan including known Gilbert's syndrome, active inflammatory bowel disease or chronic diarrhea greater than or equal to grade 2.
• Abdominal or pelvic radiation therapy within the last 12 months.
• Women who are pregnant or breastfeeding.
• Any condition (e.g., psychological, geographical) that would render the protocol treatment dangerous.
• Significant cardiac disease.
• Untreated or symptomatic brain or central nervous system (CNS).
• Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis.
• Current partial or complete bowel obstruction.
• Concomitant active infection.
• Enrolled in any other investigational trial, unless treatment in that trial has been discontinued at least 30 days prior to signing the Informed Consent for the ACO-002 study.

Sponsors & Collaborators

• Alchemia Oncology: lead

Study Sites (5)

Southern Medical Day Care Centre

Wollongong, New South Wales, 2500, Australia

Location

Western General Hospital

Melbourne, Victoria, 3011, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3165, Australia

Location

Border Medical Oncology

Wodonga, Victoria, 3690, Australia

Location

Related Publications (1)

• Gibbs P, Clingan PR, Ganju V, Strickland AH, Wong SS, Tebbutt NC, Underhill CR, Fox RM, Clavant SP, Leung J, Pho M, Brown TJ. Hyaluronan-Irinotecan improves progression-free survival in 5-fluorouracil refractory patients with metastatic colorectal cancer: a randomized phase II trial. Cancer Chemother Pharmacol. 2011 Jan;67(1):153-63. doi: 10.1007/s00280-010-1303-3. Epub 2010 Mar 24.

  PMID: 20333384 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Peter Gibbs, MD

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 7, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2015
• Last Updated: April 29, 2015

Record last verified: 2014-08

Locations

AU (5)