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A Phase I/II Study Of Neoadjuvant Chemotherapy, Angiogenesis Inhibitor SU5416 (NSC # 696819; A TK Inhibitor Anti-Angionesises Compound), And Radiation Therapy In The Management Of High Risk, High-Grade, Soft Tissue Sarcomas Of The Extremities And Body Wall

Phase 1/Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

A Phase I/II Study Of Neoadjuvant Chemotherapy, Angiogenesis Inhibitor SU5416 (NSC # 696819; A TK Inhibitor Anti-Angionesises Compound), And Radiation Therapy In The Management Of High Risk, High-Grade, Soft Tissue Sarcomas Of The Extremities And Body Wall


- Determine the maximum tolerated dose of SU5416 when administered with neoadjuvant
chemotherapy and radiotherapy and adjuvant chemotherapy in patients with high-grade
stage IIC-III soft tissue sarcoma.

- Determine the disease-free survival, local control, and overall survival in patients
treated with this regimen.

- Determine histological response in patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

- Determine the quantitative antiangiogenic effects of SU5416 in patients treated with
this regimen.

OUTLINE: This is a dose-escalation study of SU5416.

Patients receive neoadjuvant chemotherapy comprising doxorubicin, ifosfamide, and
dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients also receive filgrastim
(G-CSF) subcutaneously once daily beginning on day 5 and continuing until blood counts
recover. Patients undergo 2 courses of radiotherapy, given once daily for 11 doses per
course over days 7-20 and 28-41. Patients also receive SU5416 IV over 1 hour twice weekly
beginning on day 1 and continuing until 2 days before surgery. Patients undergo surgical
resection on day 80. Patients then receive adjuvant chemotherapy comprising doxorubicin,
ifosfamide, and dacarbazine IV continuously on days 101-103, 122-124, and 143-145. Patients
also receive SU5416 IV over 1 hour twice weekly beginning on day 101 and continuing until
the end of adjuvant chemotherapy. Patients with positive surgical margins receive additional
radiotherapy beginning 2 weeks after resection for a total of 8 doses.

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.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: Approximately 68-80 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed stage IIC-III primary or locally recurrent soft tissue

- Grade 2 or 3 on grade 1-3 scale OR

- Grade 3 or 4 on grade 3-4 scale

- Tumor size at least 8 cm in diameter

- Tumor located on upper extremities (including shoulder), lower extremities (including
hip), or on body wall

- No rhabdomyosarcoma, extraosseous Ewing's sarcoma, primitive neuroectodermal tumors,
osteosarcoma or chondrosarcoma, Kaposi's sarcoma or angiosarcoma of the scalp or
face, or any sarcoma of the head and neck

- No evidence of lung metastases

- Maximum of 4 chest lesion no greater than 3 mm in diameter each on preoperative chest
CT scans

- Lesions no greater than 1 cm in diameter allowed if stable for at least 1 year
and fit criteria for granulomas



- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- At least 2 years


- WBC at least 4,000/mm^3 OR

- Absolute neutrophil count at least 1,800/mm^3

- Platelet count at least 150,000/mm^3

- No prior bleeding or clotting diathesis


- Bilirubin no greater than 1.5 mg/dL

- AST and ALT no greater than 1.5 times upper limit of normal

- PT and PTT less than 1.25 times normal (not on coumadin)


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min


- LVEF greater than 50%

- History of atherosclerotic coronary artery disease (CAD) requiring bypass surgery
allowed provided surgery occurred at least 1 year prior to study entry

- No uncompensated CAD on electrocardiogram or physical examination

- No myocardial infarction or severe or unstable angina within the past 6 months

- No New York Heart Association class II-IV heart disease

- No congestive heart failure

- No severe peripheral vascular disease

- No peripheral vascular disease with diabetes mellitus

- No deep venous or arterial thrombosis (including pulmonary embolism) within the past
3 months


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Fibrin split products less than 2 times normal

- Fibrinogen greater than 200 mg/dL

- No active uncontrolled bacterial, viral, or fungal infection

- No known hypersensitivity to E. coli-derived proteins

- No contraindications to limb-salvage surgery

- No other prior or concurrent malignancy within the past 5 years except surgically
treated carcinoma in situ of the cervix or squamous or basal cell skin cancer

- No other serious medical or psychiatric illness that would preclude study


Biologic therapy:

- No prior biologic therapy


- No prior chemotherapy

Endocrine therapy:

- Not specified


- No prior radiotherapy


- More than 2 weeks since minor surgery

- More than 4 weeks since major surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Burton L. Eisenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2001

Completion Date:

October 2003

Related Keywords:

  • Sarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage II adult soft tissue sarcoma
  • Sarcoma



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