A trial looking at patupilone (Epo906) for people with advanced bowel cancer (CINATRA)

Please note this trial is no longer recruiting patients.

This trial is looking at a new chemotherapy drug called patupilone for people with bowel cancer (colorectal cancer) that has spread locally, or to other parts of the body (metastatic).

Advanced bowel cancer is usually treated with chemotherapy. Capecitabine, oxaliplatin and irinotecan are some of the standard chemotherapy drugs used. These drugs may help to control the growth of the cancer and to relieve symptoms. But if the cancer continues to grow or comes back, it becomes more difficult to treat.

An earlier phase 1 trial looked at patupilone (also called Epo906) in people who had already had standard chemotherapy for bowel cancer. Some people’s cancer shrank or stayed the same. So the results were promising but they need to be confirmed with a larger number of patients.

Bowel cancers have different types of changes in the DNA. Most have changes called chromosomal instability. A small number have DNA changes called microsatellite instability. Patupilone works by stopping the cancer’s DNA growing. And doctors think that it may work differently, depending on the type of change in the cancer’s DNA.

This trial aims to find out if patupilone

Can shrink or control the growth of bowel cancer
Works better for bowel cancer when the DNA has microsatellite instability rather than chromosomal instability

Recruitment

Start 10/12/2008

End 01/05/2010

Phase

Phase 2

Who can enter

You can enter this trial if you

Have cancer of the bowel (colon or rectum) that has spread locally or to other parts of your body
Have already had treatment with oxaliplatin, irinotecan and either raltitrexed or a fluoropyrimidine drug (a group of drugs including fluorouracil or 5FU, capecitabine, tegafur with uracil (Uftoral))
Have cancer that can be measured on a CT scan
Have biopsies (samples) of your cancer in storage that can be looked at by researchers in this trial
Are well enough to take part in this trial (performance status 0 or 1)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception during and for 1 month after treatment if there is a chance that you or your partner could become pregnant

To enter the second part of this trial, you must have microsatellite instability, rather than chromosomal instability. The trial doctors will test a sample of your cancer to check this.

You cannot enter this trial if you

Are still having severe side effects as a result of previous treatments
Have had in the past year a heart attack, severe or unstable angina, a coronary or peripheral artery bypass graft or congestive heart failure that is causing symptoms
Have had a stroke, mini stroke (transient ischemic attack) or blood clot in your lungs (pulmonary embolism) in the past year
Have had any other cancer in the past 5 years (apart from non melanoma skin cancer or cervical cancer in situ which have been treated)
Are pregnant or breast feeding

Trial design

This phase 2 trial has 2 different parts. It will recruit 75 people into the first part (group A). Once all the people have been recruited into group A, it will recruit 35 more people into group B.

The trial team will get tissue samples taken when you had surgery or a biopsy. And they may ask you to have another biopsy. They will check the type of DNA changes you have.

People in group A can have either chromosomal instability or microsatellite instability DNA changes. But you can only take part in group B if you have microsatellite instability.

The trial doctors will ask a lot of people to have their tissue samples tested for group B. But being tested does not mean that you will be able to take part. Only about 10 to 15 of every 100 (10 to 15%) have microsatellite instability.

In both parts of the trial, everybody will have patupilone through a drip into a vein every 3 weeks. This takes about 30 minutes. Each 3 week period is called a cycle of treatment. You have 8 cycles of treatment over about 6 months. You may continue treatment for longer if scans show that your cancer has not grown or spread.

You will fill out a questionnaire at the start of the trial, during some of your appointments for treatment and at your follow up appointments. This will ask you how you have been feeling. It is called a ‘quality of life’ study.

Hospital visits

Before you start your treatment, a doctor will examine you ask questions about your health and whether others in your family had had cancer. You will have various tests, these include

An ECG (heart trace)
CT scan
Blood tests
Urine test

You will visit hospital every 3 weeks for treatment. You have further blood tests and a urine test before each cycle of patupilone. You will have a CT scan every 3 months during treatment. If this shows that your cancer has not grown or spread, you may continue with the treatment.

After you have finished patupilone treatment, you have outpatient appointments every 3 months. You will have blood tests, an examination and possibly an X-ray or CT scan.