NCT00023738
Chemotherapy, SU5416, Radiation Therapy, and Surgery in Treating Patients With Soft Tissue Sarcoma
PHASE1
PHASE2
COMPLETED
NCT00023738
INTERVENTIONAL
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy, SU5416, and radiation therapy before and after surgery may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy, SU5416, radiation therapy, and surgery in treating patients who have soft tissue sarcoma.
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IIC-III primary or locally recurrent soft tissue sarcoma
* 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
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1
Life expectancy:
* At least 2 years
Hematopoietic:
* 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
Hepatic:
* 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)
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* 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
Other:
* 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 participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* More than 2 weeks since minor surgery
* More than 4 weeks since major surgery
Sarcoma
- TREATMENT
-
- Type: BIOLOGICAL
- Name: filgrastim
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: dacarbazine
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: doxorubicin hydrochloride
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: ifosfamide
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: semaxanib
- Description:
- Arm Group Labels:
-
- Type: PROCEDURE
- Name: conventional surgery
- Description:
- Arm Group Labels:
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels:
- Radiation Therapy Oncology Group