Back to resultsCombination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
Primary Purpose
Kidney Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
doxorubicin hydrochloride
ifosfamide
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer
Eligibility 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
Sites / Locations
- Institut Sainte Catherine
- Centre Leon Berard
- Institut J. Paoli and I. Calmettes
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- CRLCC Nantes - Atlantique
- Centre Antoine Lacassagne
- C.H.U. - Hopital Gaston Doumergue
- Hotel Dieu de Paris
- Institut Curie - Section Medicale
- Institut Jean Godinot
- Centre Eugene Marquis
- Centre Rene Huguenin
- Centre Hospitalier General de Saint Nazaire
- Institut Gustave Roussy
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00003683
Brief Title
Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
Official Title
Treatment of Sarcomatous Kidney Cancer That is Metastatic in Adults With Doxorubicin and Ifosfamide. Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 1998 (Actual)
Primary Completion Date
November 5, 2000 (Actual)
Study Completion Date
April 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
ifosfamide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Culine, MD
Organizational Affiliation
Institut du Cancer de Montpellier - Val d'Aurelle
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
C.H.U. - Hopital Gaston Doumergue
City
Nimes
ZIP/Postal Code
30006
Country
France
Facility Name
Hotel Dieu de Paris
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Institut Curie - Section Medicale
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35064
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
Centre Hospitalier General de Saint Nazaire
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
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