Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
|ClinicalTrials.gov Identifier: NCT00003683|
Recruitment Status : Unknown
Verified May 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2004
Last Update Posted : July 24, 2008
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Official Title:||Treatment of Sarcomatous Kidney Cancer That is Metastatic in Adults With Doxorubicin and Ifosfamide. Phase II Study|
|Study Start Date :||March 1998|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003683
|Institut Sainte Catherine|
|Avignon, France, 84082|
|Centre Leon Berard|
|Lyon, France, 69373|
|Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|C.H.U. - Hopital Gaston Doumergue|
|Nimes, France, 30006|
|Hotel Dieu de Paris|
|Paris, France, 75181|
|Institut Curie - Section Medicale|
|Paris, France, 75248|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Eugene Marquis|
|Rennes, France, 35064|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Centre Hospitalier General de Saint Nazaire|
|Saint Nazaire, France, 44600|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Stephane Culine, MD||Institut du Cancer de Montpellier - Val d'Aurelle|