Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis [PERCY QUATTRO]
- Determine the overall survival of patients with metastatic renal cell adenocarcinoma
treated with medroxyprogesterone vs recombinant interferon alfa-2a and/or aldesleukin.
- Determine the objective response rate (complete and partial) of patients treated with
- Determine the progression-free survival of patients treated with these regimens.
- Determine the toxicity of these regimens in these patients.
- Evaluate the quality of life of patients before and after induction treatment with
these regimens (week 10).
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are
randomized to 1 of 4 treatment arms.
- Arm I (medroxyprogesterone): Patients receive oral medroxyprogesterone once daily for
12 weeks. Patients may receive a second 12-week course in the presence of responding or
stable disease. Quality of life is assessed at baseline and at weeks 12 and 24.
- Arm II (recombinant interferon alfa-2a): Patients receive recombinant interferon
alfa-2a subcutaneously (SC) 3 times weekly for 12 weeks. Patients may receive a second
12-week course in the presence of responding or stable disease. Quality of life is
assessed as in arm I.
- Arm III (aldesleukin): Patients receive aldesleukin SC twice daily on days 1-5, 8, 9,
15, 16, 22, and 23 and once daily on days 10-12, 17-19, and 24-26. Courses repeat
beginning in weeks 6, 13, and 20. Quality of life is assessed at baseline and at weeks
10 and 24.
- Arm IV (recombinant interferon alfa-2a and aldesleukin): Patients receive recombinant
interferon alfa-2a as in arm II and receive aldesleukin as in arm III. Quality of life
is assessed as in arm III.
After completion of study treatment, patients are followed periodically for 5 years and then
PROJECTED ACCRUAL: A total of 456 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Sylvie Negrier, MD
Centre Leon Berard
United States: Federal Government