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Chemotherapy in Treating Patients With Advanced Sarcoma - Article


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Connective Tissue Disorders

Connective Tissue Disease; Dupuytren's Contracture; Mixed Connective Tissue Disease; PXE




Clinical Trial: Chemotherapy in Treating Patients With Advanced Sarcoma

This study is no longer recruiting patients.

Sponsored by: Swiss Institute for Applied Cancer Research
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
stage IVB adult soft tissue sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
stage IVA adult soft tissue sarcoma
recurrent uterine sarcoma
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
ovarian sarcoma
 Drug: doxorubicin
 Drug: filgrastim
 Drug: ifosfamide
Phase II

MedlinePlus related topics:  Soft Tissue Sarcoma;   Uterine Cancer;   Uterine Fibroids

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of High-Dose Ifosfamide and Doxorubicin in Patients With Advanced Soft Tissue or Gynecological Sarcoma

Further Study Details: 

Study start: 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.

PROTOCOL 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   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically proven advanced soft tissue or gynecologic sarcoma
  • Measurable disease
  • No brain metastases (CT scan required if metastases are clinically suspected)

--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

--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

Location Information


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

Study chairs or principal investigators

Serge Leyvraz,  Study Chair,  Swiss Institute for Applied Cancer Research   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Publications

Cerny T, Leyvraz S, von Briel T, Kupfer A, Schaad R, Schmitz SF, Honegger P, Sessa C, Brunner J, Boddy AV. Saturable metabolism of continuous high-dose ifosfamide with mesna and GM-CSF: a pharmacokinetic study in advanced sarcoma patients. Swiss Group for Clinical Cancer Research (SAKK). Ann Oncol. 1999 Sep;10(9):1087-94.

Study ID Numbers:  CDR0000078339; SWS-SAKK-57/93; EU-93004
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002526
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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December 2, 2008



Page Updated: September 6, 2005
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