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Treatment of Sarcomatous Kidney Cancer That is Metastatic in Adults With Doxorubicin and Ifosfamide. Phase II Study

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

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Trial Information

Treatment of Sarcomatous Kidney Cancer That is Metastatic in Adults With Doxorubicin and Ifosfamide. Phase II Study

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.

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.

Inclusion 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

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

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephane Culine, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

Related Keywords:

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