Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer

Sponsor

Centre Leon Berard (Other)

Overall Status

Completed

CT.gov ID

NCT00416429

Collaborator

(none)

456

Enrollment

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Biological: aldesleukin Biological: recombinant interferon alpha-2a Drug: medroxyprogesterone	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

456 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Feb 1, 2005

Outcome Measures

Primary Outcome Measures

Overall survival []

Secondary Outcome Measures

Objective response rate (complete and partial) []
Progression-free survival []
Toxicity []
Quality of life in week 10 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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