Trial of FOLF(HA)Iri With Cetuximab in mCRC
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Drug: HA-Irinotecan
- Registration Number
- NCT02216487
- Lead Sponsor
- Western General Hospital, Australia
- Brief Summary
As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced efficacy in both nonclinical and early clinical studies.
The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild type metastatic colorectal cancer. The study objectives are to confirm the safety and efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic colorectal cancer patients.
It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent treatment and follow up; thus the trial will run for approximately 2-3 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HA-Irinotecan HA-Irinotecan HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan.
- Primary Outcome Measures
Name Time Method Safety 2 years To assess FOLF(HA)iri plus cetuximab with respect to:
Patient safety, including incidence of severe (Grade 3/4) toxicity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
Western General Hospital
🇦🇺Melbourne, Victoria, Australia
Southern Medical Day Care Centre
🇦🇺Wollongong, New South Wales, Australia