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A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma


Phase 3
18 Years
81 Years
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma


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.

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:

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Safety Issue:

No

Principal Investigator

Martin E. Gore, MD

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United States: Federal Government

Study ID:

CDR0000269480

NCT ID:

NCT00053820

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

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