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A randomised phase II study of Irinotecan, 5-Fluorouracil and Folinic Acid (FOLFIRI) with or without the addition of an endothelin receptor antagonist in patients with metastatic colorectal cancer after failure of Oxaliplatin-containing chemotherapy.


The prognosis for patients with advanced colorectal cancer (aCRC) is poor. Approximately 16,000 patients in the UK die from the disease [1]. Despite new chemotherapy regimens treatment for these patients is still considered palliative rather than curative and only 5 out of every 100 patients survive 5 years after diagnosis.

Targetting cancer cells

ZD4054 is an oral drug that blocks key messages that cancer cells need to survive and grow. Clinical trial data has recently demonstrated that ZD4054 is highly active and generally well tolerated in the treatment of prostate cancer. Laboratory studies have shown that adding drugs similar to ZD4054 to existing chemotherapy regimens makes them more effective at killing cancer cells.

Trial aim

This clinical trial aims to see whether the addition of ZD4054 to FOLFIRI chemotherapy, a regimen widely used for patients with aCRC will make this drug regimen more effective at killing colorectal cancer cells such that disease progression is delayed.

One hundred and twenty two patients who have been diagnosed with aCRC and have failed to respond to treatment with an oxaliplatin chemotherapy regimen will be recruited over a one year period and randomised to receive a maximum of 12 cycles of FOLFIRI chemotherapy plus either a placebo or oral ZD4054.

A specific set of toxicity criteria will be used to monitor any treatment induced side-effects and provide the justification for any necessary dose modifications or withdrawal of treatment.

If results suggest that the combination of FOLFIRI chemotherapy plus oral ZD4054 is sufficiently effective, tolerable and feasible then it will be the intention of the trial team to take the combination forward to treat aCRC patients in a randomised Phase III setting.


The FOLFERA trial results have not yet been published but are pending.


Chief Investigator(s)
Funder(s) AstraZeneca
Sponsor Cardiff University
ISRCTN 73199181

Key facts

Start date 7 Apr 2010
End date 6 Aug 2012
  • Closed to recruitment

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