A Randomized Phase I/II Study Of Preoperative Radiotherapy With/Without SUGEN 5416 (NSC # 696819; A TK Inhibitor Anti-Angiogenesis Compound) In The Management Of Low To Intermediate Grade Soft Tissue Sarcoma Of The Trunk or Extremity
A Randomized Phase I/II Study Of Preoperative Radiotherapy With/Without SUGEN 5416 (NSC # 696819; A TK Inhibitor Anti-Angiogenesis Compound) In The Management Of Low To Intermediate Grade Soft Tissue Sarcoma Of The Trunk or Extremity
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if radiation therapy is more effective with or without SU5416 in treating soft tissue sarcoma.
PURPOSE: Phase I/II trial to compare the effectiveness of radiation therapy with or without SU5416 in treating patients who have stage IB or stage IIA soft tissue sarcoma.
OBJECTIVES:
OUTLINE: This is a phase I dose-escalation study of SU5416 followed by a phase II randomized study.
Phase I:
Phase II:
All patients undergo surgical resection 70-80 days after beginning therapy. Patients with positive surgical margins receive additional radiotherapy daily for 8 days and SU5416 IV over 1 hour on days 2, 4, and 9.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for phase I of this study within 1 year. Approximately 28 patients will be accrued for phase II of this study.
DISEASE CHARACTERISTICS:
Histologically confirmed primary or locally recurrent stage IB or IIA soft tissue sarcoma
Tumor located on upper extremities (including shoulder), lower extremities (including hip), or body wall
No sarcoma of the head and neck or intra-abdominal or retroperitoneal sarcoma
No desmoid tumor or dermatofibrosarcoma protuberans
No metastatic disease
No evidence of lung metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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