Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: aldesleukin Biological: recombinant interferon alpha-2a Drug: medroxyprogesterone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: 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] |
- Overall survival [ Designated as safety issue: No ]
- Objective response rate (complete and partial) [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Quality of life in week 10 [ Designated as safety issue: No ]
| Estimated Enrollment: | 456 |
| Study Completion Date: | February 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
Additional Information:
Publications:
| Responsible Party: | Centre Leon Berard |
| ClinicalTrials.gov Identifier: | NCT00416429 History of Changes |
| Other Study ID Numbers: | CDR0000468571, LEONB-PERCY-QUATTRO, EU-20605, LEONB-ET99-058, ROCHE-LEONB-PERCY-QUATTRO, CHIRON-LEONB-PERCY-QUATTRO |
| Study First Received: | December 27, 2006 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centre Leon Berard:
|
recurrent renal cell cancer stage IV renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a Interferons |
Aldesleukin Medroxyprogesterone Acetate Medroxyprogesterone Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Contraceptives, Oral, Synthetic |
ClinicalTrials.gov processed this record on June 17, 2013