RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus doxorubicin in treating patients who have resectable primary or recurrent peritoneal soft tissue sarcoma.

Condition	Treatment or Intervention	Phase
adult liposarcoma stage IIC adult soft tissue sarcoma recurrent adult soft tissue sarcoma adult leiomyosarcoma stage III adult soft tissue sarcoma	Drug: doxorubicin	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of preoperative external beam radiotherapy when combined with doxorubicin and followed by intraoperative radiotherapy in patients with resectable primary or recurrent soft tissue sarcomas of the retroperitoneum. II. Assess radiologic and pathologic response to this preoperative regimen in these patients.

PROTOCOL OUTLINE: This is a dose escalation study of external beam radiotherapy. Patients receive doxorubicin IV bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks. Patients with stable or responding disease undergo surgical resection of primary tumor and all adjacent gross disease approximately 6 weeks following completion of chemoradiotherapy. Patients receive intraoperative radiotherapy (IORT) to the tumor bed if all gross disease has been resected and if the area of maximal tumor adherence to the retroperitoneum can be encompassed within a single IORT field (maximum 15 cm). Cohorts of 3-6 patients receive escalating doses of external beam radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 30% of patients experience grade 3 or worse dose limiting toxicity.

PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically proven resectable primary or recurrent soft tissue sarcoma of the retroperitoneum; Greatest dimension of the 3 dimensional assessment of tumor size must be 5-35 cm; Grade 2 or 3, including dedifferentiated liposarcoma and retroperitoneal recurrences of gastrointestinal leiomyosarcoma

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: Not specified
• Radiotherapy: No prior abdominal radiotherapy
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 70-100% Zubrod 0 or 1
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count greater than 2,000/mm3; Platelet count at least 100,000/mm3
• Hepatic: Not specified
• Renal: Normal renal function; Creatinine less than 1.6 mg/dL
• Gastrointestinal: Must maintain adequate oral nutrition (90-100% of estimated need for calories and protein) and be free of nausea and vomiting prior to radiotherapy (feeding tube allowed)
• Other: Prior malignancy allowed at the discretion of the protocol investigator; No other serious uncontrolled medical condition; Not pregnant or nursing; Fertile patients must use effective contraception

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Peter W. T. Pisters,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000067350; MDA-ID-95225; NCI-G99-1606
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004123
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08