Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information

Alternate Title

Leucovorin and Fluorouracil Compared With Raltitrexed in Treating Patients With Stage III Colon Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over EORTC-40962 PETACC-1

Objectives

I.  Compare the effect of raltitrexed vs leucovorin calcium-modulated bolus 
fluorouracil on recurrence-free survival and duration of survival in patients 
with previously resected stage III (Duke's C) colon cancer.

II.  Compare the safety of these treatments in these patients.

III.  Evaluate the effect of different doses of fluorouracil on toxicity in 
these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed stage III (Duke's C) colon cancer

Curative radical resection performed within 6 weeks prior to study entry

Prior/Concurrent Therapy:

Biologic therapy:
 No concurrent biologic therapy

Chemotherapy:
 No prior chemotherapy 
 No other concurrent chemotherapy 

Endocrine therapy:
 No concurrent endocrine therapy 

Radiotherapy:
 Not specified

Surgery:
 See Disease Characteristics

Other:
 No other concurrent systemic anticancer therapy allowed
 No concurrent vitamin supplements containing folic acid

Patient Characteristics:

Age:
 18 and over

Performance status:
 WHO 0 or 1

Life expectancy:
 Not specified

Hematopoietic:
 WBC at least 4,000/mm3
 Absolute neutrophil count at least 2,000/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 SGOT/SGPT no greater than 1.5 times upper limit of normal (ULN)

Renal:
 Creatinine no greater than 1.5 times ULN

Other:
 Not pregnant or nursing
 Effective contraception required of fertile patients
 No concurrent serious thromboembolic event under treatment
 Blood donations may not be made during study treatment and for 3 months
  following last dose of study treatment
 No other malignancy within past 10 years except nonmelanomatous nonsquamous
  skin cancer and adequately treated carcinoma in situ of the cervix

Expected Enrollment

A total of 2,765 patients will be accrued for this study over 2 years.

Outline

This is a randomized, parallel group, multicenter study.

Patients are randomized to 1 of 2 arms.

Arm I (standard arm):  Patients receive leucovorin calcium followed by 
fluorouracil, both given by IV bolus, for 5 consecutive days; treatment is 
repeated every 4 weeks for a total of 6 courses (24 weeks).

Arm II (raltitrexed arm):  Patients receive raltitrexed as a 15 minute 
infusion IV once every 3 weeks; treatment is repeated for a total of 8 courses 
(24 weeks).

Patients are followed every 6 months for 3 years and yearly thereafter.

Drug-company decision to end cancer trial. Lancet 354 (9184): 1045, 1999.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Jacques Wils, MD, Protocol chair(Contact information may not be current)		Ph: 31-475-334-526