RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in treating patients who have metastatic kidney cancer.

Condition	Treatment or Intervention	Phase
Stage IV Renal Cell Cancer	Procedure: chemotherapy  Drug: doxorubicin  Drug: ifosfamide	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the efficacy in terms of objective response after treatment with ifosfamide and doxorubicin in patients with metastatic sarcomatoid renal cell cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the effect of this regimen on the survival of these patients.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive doxorubicin IV on day 1 and ifosfamide IV over 2 hours on days 1 and 2. Treatment is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven metastatic, sarcomatoid renal cell carcinoma
• Measurable disease; At least 15 mm for pulmonary sites; At least 20 mm for other sites
• No uncontrolled CNS metastases

--Prior/Concurrent Therapy--

• Biologic therapy: No prior immunotherapy
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: WHO 0-2
• Life expectancy: Greater than 3 months
• Hematopoietic: Neutrophil count greater than 1500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 9 g/dL
• Hepatic: Bilirubin less than 1.5 times normal; Transaminases less than 2 times normal (less than 4 times normal if due to liver metastases)
• Renal: Creatinine less than 1.6 mg/dL; Creatinine clearance greater than 60 mL/min
• Other: No contraindication to anthracycline treatment; No unstable major organ defect; No prior malignancy except basal cell skin cancer or carcinoma in situ of the uterus; Not pregnant or nursing; Fertile patients must use effective contraception

France
      C.H.U. - Hopital Gaston Doumergue, Nimes,  30006,  France
      Centre Antoine Lacassagne, Nice,  06189,  France
      Centre Eugene Marquis, Rennes,  35064,  France
      Centre Hospitalier General de Saint Nazaire, Saint-Nazaire,  44600,  France
      Centre Leon Berard, Lyon,  69373,  France
      Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier,  34298,  France
      Centre Rene Huguenin, Saint Cloud,  92211,  France
      CRLCC Nantes - Atlantique, Nantes-Saint Herblain,  44805,  France
      Hotel Dieu de Paris, Paris,  75181,  France
      Institut Curie - Section Medicale, Paris,  75248,  France
      Institut Gustave Roussy, Villejuif,  F-94805,  France
      Institut J. Paoli and I. Calmettes, Marseille,  13273,  France
      Institut Jean Godinot, Reims,  51056,  France
      Institut Sainte Catherine, Avignon,  84082,  France

Study chairs or principal investigators

Stephane Culine,  Study Chair,  Federation Nationale des Centres de Lutte Contre le Cancer   

Study ID Numbers:  CDR0000066785; FRE-FNCLCC-REINSARDI; EU-98057
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003683
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08