Trial of FOLF(HA)Iri With Cetuximab in mCRC

• Status: Unknown status
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western General Hospital, Australia
• Collaborators: Alchemia Oncology; Merck Serono International SA
• Treatments: Camptothecin; Cetuximab; Irinotecan

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.