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Chemotherapy in Treating Patients With Advanced Sarcoma

This study is ongoing, but not recruiting participants.

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
Drug: doxorubicin hydrochloride
Drug: filgrastim
Drug: ifosfamide
Phase II

MedlinePlus related topics:   Cancer    Ovarian Cancer    Soft Tissue Sarcoma   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Ifosfamide    Filgrastim   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   January 1993

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002526

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois    
      Lausanne, Switzerland, CH-1011

Sponsors and Collaborators
Swiss Group for Clinical Cancer Research

Investigators
Study Chair:     Serge Leyvraz, MD     Centre Hospitalier Universitaire Vaudois    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000078339, SWS-SAKK-57/93, EU-93004
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002526
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Malignant mesenchymal tumor
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Doxorubicin
Recurrence
Soft tissue sarcomas
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Ifosfamide
Mechlorethamine
Sarcoma
Uterine sarcoma
Endocrinopathy
Isophosphamide mustard
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Antibiotics, Antineoplastic
Alkylating Agents
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on September 16, 2008




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