FOLFIRI plus ZD4054 in colorectal cancers refractory to oxaliplatin

• Research type

  Research Study

• Full title

  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

• IRAS ID

  24981

• Contact name

  Anne Thomas

• Sponsor organisation

  Cardiff University

• Eudract number

  2009-012151-23

• ISRCTN Number

  73199181

• Research summary

  The prognosis for patients with advanced colorectal cancer (aCRC) is poor. Approximately 16,000 patients die annually in the UK from colorectal cancer (aCRC). 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.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. FOLFERA is a randomised phase II clinical trial that 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 patients disease progression is delayed. One hundred and four patients who have been diagnosed with a CRC and have failed to respond to treatment with an oxaliplatin chemotherapy regimen will be recruited over a two year period. All patients will receive a maximum of 12 cycles of FOLFIRI chemotherapy. In addition, half the patients will receive oral ZD4054; the rest will take a dummy (placebo) tablet. A computer will be used to randomly assign patients ZD4054 or placebo. 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 the combination will be taken forward to treat aCRC patients in a randomised Phase III setting.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/88

• Date of REC Opinion

  30 Sep 2009

• REC opinion

  Favourable Opinion