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

Primary Purpose

Metastatic Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
HA-Irinotecan
Sponsored by
Western General Hospital, Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring mCRC, colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Liverpool Hospital
  • Southern Medical Day Care Centre
  • Western General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HA-Irinotecan

Arm Description

HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
August 12, 2014
Last Updated
August 27, 2014
Sponsor
Western General Hospital, Australia
Collaborators
Alchemia Oncology, Merck Serono International SA
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1. Study Identification

Unique Protocol Identification Number
NCT02216487
Brief Title
Trial of FOLF(HA)Iri With Cetuximab in mCRC
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western General Hospital, Australia
Collaborators
Alchemia Oncology, Merck Serono International SA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
mCRC, colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HA-Irinotecan
Arm Type
Experimental
Arm Description
HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan.
Intervention Type
Drug
Intervention Name(s)
HA-Irinotecan
Intervention Description
HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.
Primary Outcome Measure Information:
Title
Safety
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Gibbs, MD
Email
Peter.Gibbs@mh.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gibbs, MD
Organizational Affiliation
Western General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
1871
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weng Ng, MD
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Clingan, MD
Facility Name
Western General Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Gibbs, MD
Email
Peter.Gibbs@mh.org.au
First Name & Middle Initial & Last Name & Degree
Peter Gibbs, MD

12. IPD Sharing Statement

Learn more about this trial

Trial of FOLF(HA)Iri With Cetuximab in mCRC

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