Trial of FOLF(HA)Iri With Cetuximab in mCRC

NCT02216487 | Unknown Phase 2 DMC

• 1 other identifier: ACO-004
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

Metastatic Colorectal Cancer

Keywords

mCRC; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HA-Irinotecan

EXPERIMENTAL

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

Drug: HA-Irinotecan

Interventions

HA-Irinotecan DRUG

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

HA-Irinotecan

Eligibility Criteria

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

You may qualify if:

• 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
• + 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western General Hospital, Australia: lead
• Alchemia Oncology: collaborator
• Merck Serono International SA: collaborator

Study Sites (3)

Liverpool Hospital

Sydney, New South Wales, 1871, Australia

NOT YET RECRUITING

Southern Medical Day Care Centre

Wollongong, New South Wales, 2500, Australia

NOT YET RECRUITING

Western General Hospital

Melbourne, Victoria, 3021, Australia

RECRUITING

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

  Western General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Gibbs, MD

CONTACT

Peter.Gibbs@mh.org.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

AU (3)