PERCY QUATTRO: Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis
The PERCY Quattro trial has been designed to evaluate the survival benefit of Interleukin-2
(IL2) and/or alpha interferon (IFN) for patients with intermediate chance of response in
metastatic renal cell carcinoma.
The primary objective is overall survival, and secondary objectives are progression-free
survival, response rate, toxicity, and quality of life assessed before and after induction
treatment (week 10).
Patients above 18 years of age are eligible if they have histologically confirmed, clearly
progressive metastatic renal carcinoma, more than one metastatic organ and good performance
status (Karnofsky score ≥80%), or one metastatic organ with Karnofsky score 80%, normal
blood and liver functions with creatinine level <= 160 µmol/L.
Eligible patients will be randomly assigned in a two-by-two factorial design to either
medroxyprogesterone (MPA), subcutaneous IFN, subcutaneous IL2, or a combination of IFN and
IL2. The planned sample size is 456 patients (114 in each of the four arms). MPA is given
orally as 200 mg daily. IFN is given subcutaneously as 9 million IU three times a week. IL2
is given subcutaneously on a four-week schedule: 9 million IU twice daily for five days
followed by a two-day rest, then, on the following three weeks, 9 million IU twice daily for
two days then 9 million IU once daily on the following three days; after a week of rest, an
identical 4-week cycle is administered. IFN and IL2 combination is given using identical
routes, schedules and doses except for a reduction of IFN dose to 6 million IU per
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Sylvie Negrier, MD, PhD
Centre Leon Berard
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)