Trial of FOLF(HA)Iri With Cetuximab in mCRC

Metastatic Colorectal Cancer Clinical Trial

— Chime  

Official title:

Phase II Single Arm Trial of FOLF(HA)Iri Plus Cetuximab in Irinotecan-naïve Second Line Patients With KRAS Wild Type Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02216487
• Other study ID #: ACO-004
• Status: Recruiting
• Phase: Phase 2
• First received: August 12, 2014
• Last updated: August 27, 2014
• Start date: June 2014
• Est. completion date: November 2016

Study information

• Verified date: August 2014
• Source: Western General Hospital, Australia
• Contact: Peter Gibbs, MD
• Email: Peter.Gibbs[@]mh.org.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Tumour is KRAS wild type

• mCRC with disease progression after first-line chemotherapy (adjuvant chemotherapy is considered first line chemotherapy if metastatic progression occurs within 6 months of the end of the adjuvant chemotherapy).

• Irinotecan naïve

• Prior use of bevacizumab in the 1st line setting is permitted.

• ECOG 0 or 1

• Measurable disease

• Histological proof of colorectal adenocarcinoma

• 18+ years of age

• Adequately recovered from and at least 4 weeks after recent major surgery or chemotherapy

• At least 4 weeks after treatment with a biologic monotherapy from last dose to enrolment.

• Hematology done within 14 days prior to enrolment :

• Absolute Neutrophil count (ANC) greater than 1.5 x 109/L

• Platelets greater than 100 x 109/L

• Hemoglobin greater than or equal to 100g/L

• Chemistry done within 14 days prior to enrolment:

• AST greater than or equal to 2.5 X ULN (greater than 5 X ULN if elevation thought to be related to hepatic metastatic disease),

• Alkaline phosphatase greater than 5 x ULN,

• Serum creatinine greater than 1.5 x ULN,

• Total bilirubin greater than 34.2 µmol/L,

• Negative serum or urine pregnancy test if a WOCBP.

Exclusion criteria

• KRAS mutant.

• Prior irinotecan

• Prior anti-EGFR

• History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 5 years.

• Locally advanced or recurrent disease only

• Unsuitability for irinotecan

• Abdominal or pelvic radiation therapy (including treatment with SIR-Spheres/Sirtex) within the last 12 months.

• Women who are pregnant or breastfeeding.

• Significant cardiac disease

• Untreated or symptomatic brain or central nervous system (CNS) metastases

• Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis.

• Current partial or complete bowel obstruction.

• Concomitant active infection.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• HA-Irinotecan
HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.

Locations

Country	Name	City	State
Australia	Western General Hospital	Melbourne	Victoria
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	Southern Medical Day Care Centre	Wollongong	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
Western General Hospital, Australia	Alchemia Oncology, Merck Serono International SA

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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).	2 years	Yes