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Continuous 5 Days Infusion of High Dose Ifosfamide and Adriamycin in Patients With Advanced Sarcoma

Phase 2
18 Years
70 Years
Not Enrolling
Ovarian Cancer, Sarcoma

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Trial Information

Continuous 5 Days Infusion of High Dose Ifosfamide and Adriamycin in Patients With Advanced Sarcoma

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced soft tissue or gynecologic sarcoma
Measurable disease No brain metastases (CT scan required if metastases are clinically

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Serge Leyvraz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Hospitalier Universitaire Vaudois


Switzerland: Swissmedic

Study ID:

SAKK 57/93



Start Date:

January 1993

Completion Date:

September 1995

Related Keywords:

  • Ovarian Cancer
  • Sarcoma
  • 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
  • Sarcoma