FOLFOX plus curcumin in patients with inoperable colorectal cancer V1

• Research type

  Research Study

• Full title

  A phase I/IIa study combining curcumin (Curcumin C3 Complex, Sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer.

• IRAS ID

  28673

• Contact name

  William P Steward

• Eudract number

  2011-002289-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  37000 cases of bowel cancer present each year. Half of patients who undergo an operation in an attempt to cure the cancer develop recurrent disease in the liver. Most liver disease is inoperable and will receive first-line chemotherapy (flurouracil, Leucovorin and Oxaliplatin - "FOLFOX") in an attempt to palliate or shrink the cancer. In approximately 50% of cases this does not work due to tumour resistance to chemotherapy. In addition to this, nearly all patients experience painful side-effects (neuropathy) associated with oxaliplatin. Many of these patients are unable to tolerate chemotherapy even at reduced doses.Curcumin is a naturally occurring plant extract of the spice Turmeric. It has been extensively shown to possess anti-tumour properties in laboratory and human clinical studies either used independently or in combination with chemotherapy. It is well tolerated. It may also possess properties to prevent neuropathic side-effects.This study will combine curcumin with FOLFOX provided to patients with colorectal liver metastases. Clinical and laboratory studies will analyse the effect on tumour size, drug tolerability, side-effects and markers of prognosis or treatment. The first phase will be to demonstrate safety of combining curcumin with FOLFOX. Patients will begin on a very low dose (1 capsule) of daily curcumin and complete 2 cycles of FOLFOX. If safety is demonstrated, this dose will increase for subsequent groups of patients until a suitable target dose (up to 4 daily capsules, 2 g) is reached.The second phase will commence following satisfactory completion of phase I. This will be a two-armed study comparing patients on FOLFOX with FOLFOX Curcumin. This will continue to look at safety and tolerability but also for differences in tumour shrinkage and laboratory markers of treatment and prognosis.This could broaden the availability of chemotherapy whilst increasing operability and survival benefits. This combination may hold benefits for other forms of cancer.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  11/EM/0263

• Date of REC Opinion

  25 Aug 2011

• REC opinion

  Further Information Favourable Opinion