Sarcoma Clinical Trial
Official title:
A Phase II Study of Sorafenib and Ifosfamide as a Treatment for Patients With Sarcoma
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,
such as ifosfamide, work in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. Giving sorafenib together with
ifosfamide may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with
ifosfamide and to see how well it works in treating patients with high-grade soft tissue
sarcoma or bone sarcoma that can be removed by surgery.
OBJECTIVES:
Primary
- Assess the safety, toxicity, and efficacy of neoadjuvant sorafenib tosylate and
ifosfamide in patients with resectable high-grade soft tissue or bone sarcoma.
Secondary
- Assess the long-term efficacy or impact of therapy in these patients, in terms of the
duration of local recurrence-free survival, distant recurrence-free survival, and
disease-specific survival.
OUTLINE:
- Neoadjuvant therapy: Patients receive oral sorafenib tosylate twice daily on days 1-14
in course 1. Patients then receive oral sorafenib tosylate twice daily on days 1-28 and
ifosfamide IV continuously on days 1-7 in courses 2 and 3. Treatment repeats every 14-28
days* for 3 courses.
NOTE: *Course 1 is 14 days in duration; courses 2 and 3 are 28 days in duration.
- Surgery: At least 1 week after the completion of neoadjuvant therapy, patients undergo
surgery.
- Adjuvant therapy: Beginning ≥ 3 weeks after surgery, patients who respond to neoadjuvant
therapy receive oral sorafenib twice daily for 6 months. Patients also receive 2 courses
of ifosfamide as in courses 2 and 3 of neoadjuvant therapy.
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