Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer

NCT ID: NCT00003683

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-03-31
• Study Completion Date: 2002-04-30

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.

Conditions

Kidney Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

doxorubicin hydrochloride

Intervention Type: DRUG

ifosfamide

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephane Culine, MD

Role: STUDY_CHAIR

Institut du Cancer de Montpellier - Val d'Aurelle

Locations

Institut Sainte Catherine

Avignon, , France

Centre Leon Berard

Lyon, , France

Institut J. Paoli and I. Calmettes

Marseille, , France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, , France

Centre Antoine Lacassagne

Nice, , France

C.H.U. - Hopital Gaston Doumergue

Nîmes, , France

Hotel Dieu de Paris

Paris, , France

Institut Curie - Section Medicale

Paris, , France

Institut Jean Godinot

Reims, , France

Centre Eugene Marquis

Rennes, , France

Centre Rene Huguenin

Saint-Cloud, , France

Centre Hospitalier General de Saint Nazaire

Saint-Nazaire, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

FRE-FNCLCC-REINSARDI

Identifier Type: -

Identifier Source: secondary_id

EU-98057

Identifier Type: -

Identifier Source: secondary_id

CDR0000066785

Identifier Type: -

Identifier Source: org_study_id