Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003683
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: May 2002

November 1, 1999
July 23, 2008
March 1998
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00003683 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Kidney Cancer
  • Drug: doxorubicin hydrochloride
  • Drug: ifosfamide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Not Provided
Not Provided

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00003683
CDR0000066785, FRE-FNCLCC-REINSARDI, EU-98057
Not Provided
Not Provided
UNICANCER
Not Provided
Study Chair: Stephane Culine, MD Centre Val d'Aurelle - Paul Lamarque
National Cancer Institute (NCI)
May 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP