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Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer. Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer  Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
For Condition: stage 4 renal cell cancer
Status: No longer recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephaneCuline, Study Chair, Federation Nationale des Centres de Lutte Contre le Cancer
C.H.U. - Hopital Gaston Doumergue
Nimes, , 30006
France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Institut J. Paoli and I. Calmettes
Marseille, , 13273
France
Centre Eugene Marquis
Rennes, , 35064
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , 34298
France
Institut Jean Godinot
Reims, , 51056
France
Hotel Dieu de Paris
Paris, , 75181
France
Institut Curie - Section Medicale
Paris, , 75248
France
Institut Sainte Catherine
Avignon, , 84082
France
Centre Rene Huguenin
Saint Cloud, , 92211
France
Centre Antoine Lacassagne
Nice, , 06189
France
Centre Hospitalier General de Saint Nazaire
Saint-Nazaire, , 44600
France
Centre Leon Berard
Lyon, , 69373
France
Additional Information:
Study ID Numbers: CDR0000066785; FRE-FNCLCC-REINSARDI,EU-98057
Study Start Date: March 1998
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003683
Other Stage 4 Renal Cell Cancer Studies:
1. Study of Peripheral Stem Cell Transplantation After Chemotherapy and Radiation Therapy in Treating Patients With Metastatic Kidney Cancer
2. Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
3. Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer
4. Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
5. Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Kidney Cancer
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Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
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