Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer

Sponsor

UNICANCER (Other)

Overall Status

Completed

CT.gov ID

NCT00003683

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Drug: doxorubicin hydrochloride Drug: ifosfamide	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 1998

Actual Primary Completion Date :

Nov 5, 2000

Actual Study Completion Date :

Apr 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut Sainte Catherine	Avignon	France	84082
2	Centre Leon Berard	Lyon	France	69373
3	Institut J. Paoli and I. Calmettes	Marseille	France	13273
4	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier	France	34298
5	CRLCC Nantes - Atlantique	Nantes-Saint Herblain	France	44805
6	Centre Antoine Lacassagne	Nice	France	06189
7	C.H.U. - Hopital Gaston Doumergue	Nimes	France	30006
8	Hotel Dieu de Paris	Paris	France	75181
9	Institut Curie - Section Medicale	Paris	France	75248
10	Institut Jean Godinot	Reims	France	51056
11	Centre Eugene Marquis	Rennes	France	35064
12	Centre Rene Huguenin	Saint Cloud	France	92211
13	Centre Hospitalier General de Saint Nazaire	Saint Nazaire	France	44600
14	Institut Gustave Roussy	Villejuif	France	F-94805