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Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
Study NCT00053820   Information provided by National Cancer Institute (NCI)
First Received: February 5, 2003   Last Updated: February 6, 2009   History of Changes

February 5, 2003
February 6, 2009
July 2002
 
Survival [ Designated as safety issue: No ]
Survival
Complete list of historical versions of study NCT00053820 on ClinicalTrials.gov Archive Site
  • Time to progression as measured by RECIST criteria [ Designated as safety issue: No ]
  • Comparison of toxicity levels (Grade III and IV) [ Designated as safety issue: Yes ]
  • Comparison of quality of life before, during, after completion of study treatment [ Designated as safety issue: No ]
  • Impact of the treatment regimens on health economics [ Designated as safety issue: No ]
  • Time to progression as measured by RECIST criteria
  • Comparison of toxicity levels (Grade III and IV)
  • Comparison of quality of life before, during, after completion of study treatment
  • Impact of the treatment regimens on health economics
 
Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
A Randomized Controlled Trial of Interferon-Alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-Alpha Alone in Patients With Advanced Renal Cell Carcinoma

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 with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet known whether interferon alfa is more effective with or without interleukin-2 and fluorouracil in treating metastatic kidney cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa combined with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who have advanced metastatic kidney cancer.

OBJECTIVES:

  • Compare progression-free and overall survival of patients with advanced metastatic renal carcinoma treated with interferon alfa with or without interleukin-2 and fluorouracil.
  • Compare the toxicity of these regimens in these patients.
  • Assess the quality of life of patients treated with these regimens.

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

  • Arm I (Interferon alfa monotherapy): Patients receive interferon alfa subcutaneously (SC) on days 1, 3, and 5. Treatment continues weekly for at least 9 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II (Interferon alfa, interleukin-2, and fluorouracil combination therapy): Patients receive interferon alfa SC on day 1 of weeks 1 and 4 and days 1, 3, and 5 of weeks 2, 3, 5, 6, 7, and 8. Patients also receive interleukin-2 SC twice daily on days 3-5 of weeks 1 and 4 and once daily on days 1, 3, and 5 of weeks 2 and 3. Patients then receive fluorouracil IV on day 1 of weeks 5-8. Treatment repeats every 10 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 9, 19, and 26 weeks, and then at 8 months.

Patients are followed at 8, 10, and 12 months, every 4 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 670 patients (335 per treatment arm) will be accrued for this study.

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control
Kidney Cancer
  • Biological: aldesleukin
  • Biological: recombinant interferon alfa
  • Drug: fluorouracil
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
670
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell carcinoma

    • Advanced metastatic disease that requires treatment
  • Measurable disease (single bone lesions not included)
  • No brain metastasis

PATIENT CHARACTERISTICS:

Age

  • 18 to 81

Performance status

  • WHO 0-1

Life expectancy

  • More than 12 weeks

Hematopoietic

  • WBC greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10 g/dL

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

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

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for at least 6 months after study participation
  • No other concurrent disease or prior malignancy that would preclude study treatments or comparisons
  • No concurrent active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • No prior endocrine therapy
  • No concurrent corticosteroids

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Surgery

  • Prior resection of the primary tumor recommended but not required
  • No prior major organ allografts
Both
18 Years to 81 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Netherlands,   Slovakia
 
NCT00053820
 
CDR0000269480, MRC-RE04, EORTC-30012, EU-20231, ISRCTN46518965
Medical Research Council
European Organization for Research and Treatment of Cancer
Investigator: Martin E. Gore, MD Royal Marsden - London
Investigator: Peter F.A. Mulders, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
National Cancer Institute (NCI)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP