NCT00053820CompletedPhase 3
A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma
Medical Research Council12 sites in 4 countries670 target enrollmentStarted: July 1, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Medical Research Council
- Enrollment
- 670
- Locations
- 12
- Primary Endpoint
- Survival
Study Overview
Brief 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 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 81 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •Performance status
- •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
- •Not specified
- •Not specified
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •No unstable angina pectoris
- •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
- •Prior resection of the primary tumor recommended but not required
- •No prior major organ allografts
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Survival
Secondary Outcomes
- Comparison of toxicity levels (Grade III and IV)
- Comparison of quality of life before, during, after completion of study treatment
- Time to progression as measured by RECIST criteria
- Impact of the treatment regimens on health economics
Investigators
Study Sites (12)
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