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

Western General Hospital, Australia

Status and phase: Unknown; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: HA-Irinotecan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02216487

ACO-004

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

HA-Irinotecan

Experimental group

Description:

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

Treatment:

Drug: HA-Irinotecan