Clinical trial NCT02216487: Trial of FOLF(HA)Iri With Cetuximab in mCRC
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: mCRC
colorectal cancer
Lead sponsor: Western General Hospital, Australia
Sponsor class: OTHER
Collaborators: name: Alchemia Oncology
name: Merck Serono International SA
First posted: 2014-08-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre
state: New South Wales
city: Melbourne
country: Australia
facility: Western General Hospital
state: Victoria
Study officials:
affiliation: Western General Hospital
name: Peter Gibbs, MD
role: PRINCIPAL_INVESTIGATOR
References: