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

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

Further Study Details: 

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of doxorubicin when combined with external beam radiotherapy in patients with high risk soft tissue sarcomas of the extremity or trunk. II. Assess the radiographic and pathologic response rates to this preoperative regimen in the subset of these patients with measurable disease.

PROTOCOL OUTLINE: This is a dose escalation study of doxorubicin. Patients receive doxorubicin IV bolus followed immediately by doxorubicin IV over 4 days every week for 5 weeks in the absence of unacceptable toxicity. Patients with measurable disease receive external beam radiotherapy 5 days a week for 5 weeks concurrently with doxorubicin treatment. Patients with measurable disease undergo surgical resection of the residual mass 4-7 weeks following completion of chemoradiation. Patients who have no measurable disease and have undergone prereferral excision undergo surgical resection of the prior surgical scar and tumor bed followed by external beam radiotherapy 5 days a week for 5 weeks. Cohorts of 3 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. Patients are followed every 3 months for 3 years, every 4 months for 2 years, and then annually for 5 years.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study at a rate of 5-6 patients per month.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically proven soft tissue sarcoma of the extremity or trunk; Resectable grade 3, stage III with tumor greater than 5 cm
• Measurable disease OR nonmeasurable disease after prereferral excision

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Prior doxorubicin based systemic chemotherapy allowed if prior total dose no greater than 450 mg/m2
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy in the area of the primary tumor; Anticipated radiotherapy field must not include perineum, scrotum, or vaginal introitus
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: Over 16
• Performance status: Karnofsky 70-100%; Zubrod 0 or 1
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: SGOT or SGPT no greater than 3 times normal; Bilirubin no greater than 1.5 mg/dL
• Renal: Creatinine no greater than 1.8 mg/dL
• Cardiovascular: Ejection fraction greater than 50% for patients with prior cumulative doxorubicin dose of 450 mg/m2
• Other: Prior malignancy allowed at the discretion of the protocol investigator; No uncontrolled concurrent 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:  CDR0000067332; MDA-ID-97335; NCI-G99-1598
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004109
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08