A trial looking at VIOXX to prevent bowel cancer from coming back after treatment (VICTOR)

Cancer type:

Bowel (colorectal) cancer

Status:

Results

Phase:

Phase 3

This trial was looking at rofecoxib (VIOXX) to see if it could help stop bowel cancer from coming back (recurring) after it had been removed. This trial was for people who were thought to have a reasonably good chance of a cure. Some of the people also had chemotherapy after their operation.

Anti inflammatory drugs such as aspirin are thought to help prevent bowel cancer growing in the first place. But they do have side effects such as irritation of the stomach lining and bleeding.

A new non steroidal anti inflammatory drug (NSAID) called rofecoxib (VIOXX) was developed which had less serious side effects than other anti inflammatory drugs, such as aspirin.

The aim of this trial was to see if rofecoxib could help stop bowel cancer coming back after it had been removed by surgery.

Summary of results

This trial closed early because the drug company withdrew rofecoxib. There were some concerns that it possibly caused and increased risk of heart attacks and strokes.

The trial team found that rofecoxib did not overall decrease the risk of bowel cancer coming back but did slightly increase the risk of heart problems or strokes.

This trial was going to recruit 7,000 people. But it closed early because there were concerns about the side effects of rofecoxib and the drug company withdrew it.

At the time the trial closed it had recruited 2,434 people. Of these the trial team were able to look at the results of 2,327 people. About half had rofecoxib and half had a dummy drug – placebo.

The average amount of time these people had treatment as part of the trial was just under 7 and a half months. The average time the trial team followed them up was 33 months.

During treatment, or within 14 days of stopping, 23 people had heart problems. Of these 16 were taking rofecoxib. In the 2 years after the trial closed, another 14 people had heart problems. Of these 6 were in the rofecoxib group.

The trial team concluded that rofecoxib did not overall decrease the risk of bowel cancer coming back, but did slightly increase the risk of heart problems and strokes. They could not recommend rofecoxib as a drug to prevent bowel cancer returning.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.