Kidney Cancer Clinical Trial
Official title:
Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis [PERCY QUATTRO]
RATIONALE: Medroxyprogesterone may help shrink or slow the growth of kidney cancer.
Interferon may interfere with the growth of tumor cells. Aldesleukin may stimulate white
blood cells to kill tumor cells. It is not yet known whether giving medroxyprogesterone,
interferon, or aldesleukin alone is more effective than giving interferon together with
aldesleukin in treating kidney cancer.
PURPOSE: This randomized phase III trial is studying medroxyprogesterone, interferon, or
aldesleukin to see how well they work when given alone compared to interferon combined with
aldesleukin in treating patients with metastatic kidney cancer.
OBJECTIVES:
Primary
- Determine the overall survival of patients with metastatic renal cell adenocarcinoma
treated with medroxyprogesterone vs recombinant interferon alfa-2a and/or aldesleukin.
Secondary
- Determine the objective response rate (complete and partial) of patients treated with
these regimens.
- 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
annually thereafter.
PROJECTED ACCRUAL: A total of 456 patients will be accrued for this study.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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