Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003683

Enrollment

Registered

2004-01-27

Start date

1998-03-31

Completion date

2002-04-30

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

Brief summary

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.

Detailed description

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.

Interventions

DRUGdoxorubicin hydrochloride

DRUGifosfamide

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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 specified

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026