Trial Information

Drug Treatment for Bowel Cancer: Making the Best Choices When a Milder Treatment is Needed

OBJECTIVES:

Primary

- Compare the progression-free survival of patients with metastatic colorectal
adenocarcinoma treated with leucovorin calcium and fluorouracil with vs without
oxaliplatin or capecitabine with vs without oxaliplatin.

- Compare the quality of life of patients treated with these fluorouracil-based vs
capecitabine-based regimens.

Secondary

- Compare the failure-free and overall survival of patients treated with these regimens.

- Compare the toxic effects and adverse events associated with these regimens in these
patients.

- Compare the limited health assessments of patients treated with these regimens.

- Compare the health economics associated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4
treatment arms and receive 12 weeks of therapy.

- Arm I (MdG regimen): Patients receive leucovorin calcium IV over 2 hours on day 1 and
fluorouracil IV over 46 hours beginning on day 1. Treatment repeats every 14 days for
up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with disease progression during or within 8 weeks of the completion of this regimen
may cross over and receive second-line therapy on arm II.

- Arm II (OxMdG regimen): Patients receive leucovorin calcium IV over 2 hours and
oxaliplatin IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day
1. Treatment repeats every 14 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients with disease progression during or within 8 weeks of the completion of this regimen
may receive second-line therapy or supportive care off-study.

- Arm III (Cap regimen): Patients receive oral capecitabine twice daily on days 1-15.
Treatment repeats every 21 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.

Patients with disease progression during or within 8 weeks of the completion of this regimen
may cross over and receive second-line therapy on arm IV.

- Arm IV (OxCap regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and oral
capecitabine twice daily on days 1-15. Treatment repeats every 21 days for up to 4
courses in the absence of disease progression or unacceptable toxicity.

Patients with disease progression during or within 8 weeks of the completion of this regimen
may receive second-line therapy or supportive care off-study.

All patients are then re-evaluated at least every 6 weeks and begin another 12 weeks of
therapy at any evidence (e.g., clinical, radiological, or tumor marker) of disease
progression. Patients with chemo-sensitive disease may repeat alternating 12-week therapy
sessions and evaluation periods indefinitely.

Quality of life is assessed at baseline, at 12-14 weeks, at 24 weeks, and then every 3
months thereafter.

Patients are followed every 3 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 460 patients (115 per treatment arm) will be accrued for this
study within 2 years.