Filgrastim Compared With Filgrastim-SD/01 Following Combination Chemotherapy in Treating Patients With Newly Diagnosed Sarcoma
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim or filgrastim-SD/01 may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether filgrastim is more effective than filgrastim-SD/01 is in helping patients recover from chemotherapy.
PURPOSE: This randomized phase III trial is studying filgrastim to see how well it works compared to filgrastim-SD/01 following combination chemotherapy in treating patients with newly diagnosed sarcoma.
Description
OBJECTIVES:
- Compare the toxicity of filgrastim-SD/01 vs filgrastim (G-CSF) administered with concurrent chemotherapy in patients with newly diagnosed sarcoma.
- Compare the tolerance to these regimens by these patients.
- Compare the pharmacokinetics of these regimens in these patients.
- Compare the neutrophil recovery in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
All patients receive chemotherapy every 3 weeks for a total of 14 courses in the absence of disease progression or unacceptable toxicity. During courses 1, 2, 5, 9, 11, and 13, patients receive dexrazoxane IV over 15-30 minutes and doxorubicin IV over 15 minutes on days 1 and 2; vincristine IV on day 1 and on days 8 and 15 in courses 1, 2, 9, and 13 only; and cyclophosphamide IV over 1 hour once daily on days 1 and 2. During courses 3, 4, 6, 7, 8, 10, 12, and 14, patients receive etoposide IV over 1 hour and ifosfamide IV over 1 hour once daily on days 1-5.
- Arm I: Patients receive chemotherapy as outlined above and filgrastim (G-CSF) subcutaneously (SC) daily starting 24 hours after chemotherapy and continuing until blood counts recover.
- Arm II: Patients receive chemotherapy as in arm I and filgrastim-SD/01 SC as a single dose 24-36 hours after chemotherapy.
Local control may commence after course 5 and may consist of surgery and/or radiotherapy.
Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 34 patients (17 per treatment arm) will be accrued for this study within 2 years.
Study Design
Allocation: Randomized, Control: Active Control, Primary Purpose: Supportive Care
Conditions
Cardiac Toxicity
Intervention
filgrastim, pegfilgrastim, cyclophosphamide, dexrazoxane hydrochloride, doxorubicin hydrochloride, etoposide, ifosfamide, vincristine sulfate
Location
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda
Maryland
United States
20892-1182
Status
Active, not recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00020137
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Naphthylvinylpyridine
4(1-Naphthylvinyl)pyridine hydrochloride. Cholinesterase inhibitor. Synonym: YuB 25.
Tetramethylphenylenediamine
Used in the form of the hydrochloride as a reagent in ANALYTICAL CHEMISTRY TECHNIQUES.
Etoposide
A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.
Ambroxol
A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.
Bupropion
A unicyclic, aminoketone antidepressant. The mechanism of its therapeutic actions is not well understood, but it does appear to block dopamine uptake. The hydrochloride is available as an aid to smoking cessation treatment.
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