HA-Irinotecan Phase III trial ACO-002

• Research type

  Research Study

• Full title

  Randomized double-blind Phase III trial of FOLF(HA)iri vs FOLFIRI for second or third line therapy in irinotecan-naïve patients with metastatic colorectal cancer

• IRAS ID

  55736

• Contact name

  Ian Chau

• Sponsor organisation

  Alchemia Oncology PTY Limited

• Eudract number

  2010-020348-36

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a phase III, double blind study in patients with metastatic colorectal cancer (mCRC) as a second or third line therapy and who have not had Irinotecan as a prior therapy. The study is designed to evaluate the safety and efficacy of the test regimen, FOLF(HA)iri versus the control group FOLFIRI, the usual option for second/third line therapy in this case. FOLFIRI as a standard treatment often results in neutropenia, diarrhoea and rhinorrhoea. The addition of hyaluronic acid intravenously in combination with Irinotecan to standard treatment has shown promise in prior studies to the survival and safety of mCRC patients. The study aims to enroll 330 patients who will be allocated in a 1:1 ratio to either study arm, and continue until 290 have had disease progression or death. They will be treated with the study drug biweekly for a total of 8 months unless withdrawn. During the study patients will have their blood chemistry and haematology assessed biweekly, and receive either MRI or CT scans every 6 weeks. In addition to the main study there is an optional sub study for a total of 80 patients (40 from each arm) to evaluate Pharmacokinetic and cardiac parameters of the study drug versus the control. This sub study has its own Informed consent form. This is a phase III, double blind study in patients with metastatic colorectal cancer (mCRC) as a second or third line therapy and who have not had Irinotecan as a prior therapy. The study is designed to evaluate the safety and efficacy of the test regimen, FOLF (HA)iri versus the control group FOLFIRI, the usual option for second/third line therapy in this case. FOLFIRI as a standard treatment often results in neutropenia, diarrhoea and rhinorrhoea. The addition of hyaluronic acid intravenously in combination with Irinotecan to standard treatment has shown promise in prior studies to the survival and safety of mCRC patients. The study aims to enroll 330 patients who will be allocated in a 1:1 ratio to either study arm, and continue until 290 have had disease progression or death. They will be treated with the study drug biweekly for a total of 8 months unless withdrawn. During the study patients will have their blood chemistry and haematology assessed biweekly, and receive either MRI or CT scans every 6 weeks. In addition to the main study there is an optional sub study for a total of 80 patients (40 from each arm) to evaluate Pharmacokinetic and cardiac parameters of the study drug versus the control. This sub study has its own Informed consent form.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/98

• Date of REC Opinion

  31 Jan 2011

• REC opinion

  Further Information Favourable Opinion