Interleukin-2, Interferon Alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase

Completed

Phase 3

Conditions

Kidney Cancer

Treatments

Biological: aldesleukin

Procedure: adjuvant therapy

Biological: recombinant interferon alfa

Drug: fluorouracil

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT00053807

EORTC-30955

Details and patient eligibility

About

RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa and interleukin-2 with fluorouracil may kill any remaining tumor cells following surgery. It is not yet known whether combining interferon alfa and interleukin-2 with fluorouracil is more effective than observation after surgery for kidney cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combining interleukin-2, interferon alfa, and fluorouracil to that of observation alone in treating patients who have undergone surgery for kidney cancer and are at high risk of relapse.

Full description

OBJECTIVES:

Compare the effect of adjuvant combination therapy comprising interleukin-2, interferon alfa, and fluorouracil vs observation only on disease-free survival or overall survival of patients with renal cell carcinoma at high risk of relapse after radical surgery.
Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive interleukin-2 subcutaneously (SC) on days 3, 4, and 5 of weeks 1 and 4 and on days 1, 3, and 5 of weeks 2 and 3. Patients also receive interferon alfa SC once weekly during weeks 1 and 4 and 3 times weekly during weeks 2, 3, 5, 6, 7, and 8. Patients then receive fluorouracil IV on day 1 of weeks 5, 6, 7, and 8.
Arm II (control arm): Patients receive no adjuvant treatment before disease progression.

Quality of life is assessed at baseline and at 2 and 6 months after randomization.

Patients are followed monthly for 3 months (arm I only), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study within 3 years.

Enrollment

96 patients

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary renal cell carcinoma meeting 1 of the following criteria:
- Stage T3b, T3c, or T4 tumor
- Any pT stage and nodal status pN 1 or 2
- Any pT stage and microscopic positive margins
- Presence of any microscopic vascular invasion
Underwent surgical resection of primary tumor within the past month
- Removal of clinical N+ disease required
No evidence of metastatic disease
No evidence of macroscopic residual disease

PATIENT CHARACTERISTICS:

Age

75 and under

Performance status

WHO 0-1

Life expectancy

Not specified

Hematopoietic

WBC at least 3,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Liver function tests no greater than 1.25 times upper limit of normal (ULN)

Renal

Creatinine less than 1.5 times ULN

Cardiovascular

No myocardial infarction within the past 6 months
No unstable angina pectoris

Other

Not pregnant or nursing
No prior or other concurrent malignancies that would preclude study therapy or comparisons
No other concurrent illness that would preclude study therapy
No concurrent active infections requiring antibiotic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy