Trial of FOLF(HA)Iri With Cetuximab in mCRC (Chime)

August 27, 2014 updated by: Peter Gibbs, Western General Hospital, Australia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 1871
        • Not yet recruiting
        • Liverpool Hospital
        • Principal Investigator:
          • Weng Ng, MD
      • Wollongong, New South Wales, Australia, 2500
        • Not yet recruiting
        • Southern Medical Day Care Centre
        • Principal Investigator:
          • Philip Clingan, MD
    • Victoria
      • Melbourne, Victoria, Australia, 3021
        • Recruiting
        • Western General Hospital
        • Contact:
        • Principal Investigator:
          • Peter Gibbs, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HA-Irinotecan
HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan.
Drug: HA-Irinotecan
HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 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).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western General Hospital, Australia

Collaborators

Merck Serono International SA
Alchemia Oncology

Investigators

  • Principal Investigator: Peter Gibbs, MD, Western General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 27, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACO-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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