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| Sponsored by: |
Swiss Group for Clinical Cancer Research |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002526 |
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 drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of ifosfamide and doxorubicin in patients with advanced sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Sarcoma |
Biological: filgrastim Drug: doxorubicin hydrochloride Drug: ifosfamide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | PHASE I-II STUDY OF CONTINUOUS 5 DAYS INFUSION OF HIGH-DOSE IFOSFAMIDE AND ADRIAMYCIN IN PATIENTS WITH ADVANCED SARCOMA |
| Study Start Date: | January 1993 |
OBJECTIVES: I. Determine the response rate, time to treatment failure, and survival in patients with advanced soft tissue or gynecological sarcoma treated with high-dose ifosfamide and doxorubicin.
OUTLINE: Patients receive ifosfamide IV continuously on days 1-5 and doxorubicin IV on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing through day 16 (or until day 20 if blood counts have not recovered by day 16). Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at treatment failure and then annually thereafter.
PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven advanced soft tissue or gynecologic sarcoma Measurable disease No brain metastases (CT scan required if metastases are clinically suspected)
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Liver function tests no greater than 2 times normal Albumin 4.0-6.0 g/dL Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac function normal by MUGA scan or echocardiogram Other: No other prior or concurrent malignancy except radically removed nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the bladder No prior radiotherapy to indicator lesion Surgery: Not specified
Contacts and Locations| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| Study Chair: | Serge Leyvraz, MD | Centre Hospitalier Universitaire Vaudois |
More Information
| Study ID Numbers: | CDR0000078339, SWS-SAKK-57/93, EU-93004 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002526 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage III uterine sarcoma stage IV uterine sarcoma |
recurrent uterine sarcoma ovarian sarcoma stage IV adult soft tissue sarcoma |
|
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Doxorubicin Recurrence Genital Diseases, Female Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Ifosfamide |
Malignant Mesenchymal Tumor Soft Tissue Sarcomas Mechlorethamine Uterine Sarcoma Sarcoma Ovarian Cancer Antineoplastic Agents, Alkylating Endocrinopathy Alkylating Agents Isophosphamide mustard Endocrine Gland Neoplasms |
|
Neoplasms by Histologic Type Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin |
Adnexal Diseases Genital Diseases, Female Neoplasms, Connective and Soft Tissue Ifosfamide Neoplasms Neoplasms by Site Therapeutic Uses Sarcoma Antineoplastic Agents, Alkylating Alkylating Agents Isophosphamide mustard Endocrine Gland Neoplasms |
