Chemotherapy in Treating Patients With Advanced Sarcoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002526

Enrollment

Registered

2004-03-11

Start date

1993-01-31

Completion date

1995-09-30

Last updated

2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Sarcoma

Keywords

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

Brief summary

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.

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.

Interventions

BIOLOGICALfilgrastim

DRUGdoxorubicin hydrochloride

DRUGifosfamide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026