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Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis [PERCY QUATTRO]


Phase 3
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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Trial Information

Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis [PERCY QUATTRO]


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic renal cell adenocarcinoma, meeting 1 of the
following criteria:

- More than 1 metastatic site and good performance status (Karnofsky score
80-100%)

- Sole metastatic site with Karnofsky score = 80%

- Karnofsky 90% or 100% not eligible

- No combination of several metastatic sites and liver metastases and a time
interval from primary tumor to metastases of < 1 year

- Nonmeasurable disease and/or few numbers of lesions must be confirmed histologically
and as progressive disease

- The following metastases are allowed:

- Lung with or without mediastinum lymph nodes

- Bone

- Pleura (solid or liquid with positive cytology)

- Thoracic lymph nodes

- Abdominal lymph nodes

- Superficial lymph nodes

- Liver

- Subcutaneous skin/tissue

- Contralateral kidney

- Nephrectomy site

- Other organs

- Prior metastases allowed provided the following criteria are met:

- Evidence of progressive disease within the past 3 months

- Metastases evaluated by noninvasive methods

- No evidence of active brain metastases

- Prior brain metastases allowed provided all of the following criteria are met:

- Disease is stable

- Reductive therapy (surgery or radiotherapy) completed at least 3 weeks
prior to study entry

- Metastases have not progressed (confirmed by CT scan or MRI)

- No concurrent corticosteroids required

PATIENT CHARACTERISTICS:

- See Disease Characteristics

- Creatinine < 1.8 mg/dL

- Hematocrit ≥ 30%

- WBC ≥ 4,000/mm^3

- Platelet count ≥ 120,000/mm^3

- Bilirubin normal

- LVEF ≥ 50%

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No HIV positivity

- No severe infection requiring antibiotic therapy

- No chronic hepatitis

- No severe lung, liver or kidney condition that would preclude study treatment

- No hepatitis B surface antigen positivity

- No severe neuropsychiatric condition or epilepsy

- No serious thromboembolitic disorder

- No severe cardiac dysfunction (e.g., congestive heart failure, uncontrolled
hypertension, serious arrhythmia, or coronary disease)

- No other prior or concurrent primary malignancies except for basal cell skin cancer
or carcinoma in situ of the cervix

- No geographical, psychological, or familial condition that would preclude study
participation

PRIOR CONCURRENT THERAPY:

- More than 6 weeks since prior wide-field radiotherapy

- No prior systemic chemotherapy

- No prior organ transplantation

- No prior cytokines

- No concurrent hormonal therapy

- No concurrent anticancer chemotherapy

- No concurrent corticosteroids

- No other concurrent immunotherapy

- No other concurrent investigational agents or therapies

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Sylvie Negrier, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Leon Berard

Authority:

United States: Federal Government

Study ID:

CDR0000468571

NCT ID:

NCT00416429

Start Date:

Completion Date:

February 2005

Related Keywords:

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

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