Chemotherapy in Treating Patients With Advanced Sarcoma

NCT ID: NCT00002526

Last Updated: 2012-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-01-31
• Study Completion Date: 1995-09-30

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.

Conditions

Ovarian Cancer; Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

filgrastim

Intervention Type: BIOLOGICAL

doxorubicin hydrochloride

Intervention Type: DRUG

ifosfamide

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Serge Leyvraz, MD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire Vaudois

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Countries

Switzerland

References

Leyvraz S, Zweifel M, Jundt G, Lissoni A, Cerny T, Sessa C, Fey M, Dietrich D, Honegger HP; Swiss Group for Clinical Cancer Research. Long-term results of a multicenter SAKK trial on high-dose ifosfamide and doxorubicin in advanced or metastatic gynecologic sarcomas. Ann Oncol. 2006 Apr;17(4):646-51. doi: 10.1093/annonc/mdl020. Epub 2006 Feb 24.

Reference Type: RESULT

PMID: 16500907 (View on PubMed)

Other Identifiers

EU-93004

Identifier Type: -

Identifier Source: secondary_id

SAKK 57/93

Identifier Type: -

Identifier Source: org_study_id