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

Kidney Cancer Clinical Trial

Official title:

Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053807
• Other study ID #: EORTC-30955
• Secondary ID: EORTC-30955
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2003
• Last updated: September 20, 2012
• Start date: February 1998

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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

• No other concurrent immunotherapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• No concurrent corticosteroids

• No concurrent hormonal therapy

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics

• No prior major organ allografts

Other

• No other concurrent investigational drugs, agents, or devices

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• aldesleukin

• recombinant interferon alfa

Drug:
• fluorouracil

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Hospital	Vienna
Belgium	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst
Belgium	Universitair Ziekenhuis Gent	Ghent
Belgium	AZ Groeninge - Campus St. Maarten	Kortrijk
Belgium	U.Z. Gasthuisberg	Leuven
Hungary	National Institute of Oncology	Budapest
Israel	Rambam Medical Center	Haifa
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Netherlands	Akademisch Medisch Centrum	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Jeroen Bosch Ziekenhuis	Hertogenbosch
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Daniel Den Hoed Cancer Center at Erasmus University Medical Center	Rotterdam
Netherlands	Academisch Ziekenhuis Utrecht	Utrecht
Turkey	Marmara University Hospital	Istanbul
Turkey	Dokuz Eylul University School of Medicine	Izmir
United Kingdom	Beatson Institute for Cancer Research - Glasgow	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	University of Glasgow

Countries where clinical trial is conducted

Austria,  Belgium,  Hungary,  Israel,  Italy,  Netherlands,  Turkey,  United Kingdom, 

References & Publications (1)

Aitchison M, Bray CA, Van Poppel H, et al.: Final results from an EORTC (GU Group)/NCRI randomized phase III trial of adjuvant interleukin-2, interferon alpha, and 5-fluorouracil in patients with a high risk of relapse after nephrectomy for renal cell car