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| Sponsor: | Federation Nationale des Centres de Lutte Contre le Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003683 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: doxorubicin hydrochloride Drug: ifosfamide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Treatment of Sarcomatous Kidney Cancer That is Metastatic in Adults With Doxorubicin and Ifosfamide. Phase II Study |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| France | |
| C.H.U. - Hopital Gaston Doumergue | |
| Nimes, France, 30006 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Centre Eugene Marquis | |
| Rennes, France, 35064 | |
| Centre Hospitalier General de Saint Nazaire | |
| Saint Nazaire, France, 44600 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| Centre Rene Huguenin | |
| Saint Cloud, France, 92211 | |
| Institut Sainte Catherine | |
| Avignon, France, 84082 | |
| Hotel Dieu de Paris | |
| Paris, France, 75181 | |
| Institut Curie - Section Medicale | |
| Paris, France, 75248 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Institut J. Paoli and I. Calmettes | |
| Marseille, France, 13273 | |
| Institut Jean Godinot | |
| Reims, France, 51056 | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Study Chair: | Stephane Culine, MD | Centre Val d'Aurelle - Paul Lamarque |
More Information
| Study ID Numbers: | CDR0000066785, FRE-FNCLCC-REINSARDI, EU-98057 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003683 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Urogenital Neoplasms Antibiotics, Antineoplastic Urologic Neoplasms Pharmacologic Actions Doxorubicin Carcinoma Ifosfamide Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Antineoplastic Agents, Alkylating Kidney Diseases Adenocarcinoma Alkylating Agents Isophosphamide mustard Neoplasms, Glandular and Epithelial |
