Radiation Therapy With or Without SU5416 in Treating Patients With Soft Tissue Sarcoma
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.
Procedure: conventional surgery
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||August 2001|
- Determine the maximum tolerated dose of SU5416 when combined with neoadjuvant radiotherapy in patients with stage IB or IIA soft tissue sarcoma.
- Determine the antiangiogenic effects of SU5416 in these patients.
- Determine any synergistic antiangiogenic effect of SU5416 with radiotherapy in these patients.
- Compare the disease-free survival, local recurrence, distant metastases, and overall survival rates in patients treated with neoadjuvant radiotherapy with or without SU5416.
OUTLINE: This is a phase I dose-escalation study of SU5416 followed by a phase II randomized study.
- Patients undergo radiotherapy once daily, 5 days a week, for 5 weeks. Patients also receive SU5416 IV over 1 hour twice weekly beginning on week 1 and continuing until 2 days before surgery.
- Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Once the MTD has been determined, additional patients are accrued and then randomized to receive either treatment as in phase I at the MTD vs preoperative radiotherapy alone.
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.