combination chemotherapy in treating patients with soft tissue sarcoma

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining cisplatin and doxorubicin in treating patients who have soft tissue sarcoma.

objectives: i. determine the response in patients with resectable soft tissue sarcoma of the extremity treated with neoadjuvant intra-arterial cisplatin and iv doxorubicin followed by limb-sparing procedure or amputation, adjuvant iv cisplatin and iv doxorubicin, and radiotherapy. ii. determine the chemotherapeutic response in tumor specimens of patients treated with this regimen. outline: neoadjuvant chemotherapy: patients undergo arterial cannulation followed by cisplatin intra-arterially over 4 hours on day 1 and doxorubicin iv (beginning 15 minutes after completion of cisplatin infusion) on days 1-3. treatment continues every 3 weeks for 2 courses in the absence of unacceptable toxicity. patients undergo amputation or limb-sparing wide excision, as feasible, approximately 4 weeks after the second course. if surgery cannot be scheduled at this time for logistical reasons, a third course may be administered. patients with an estimated tumor kill of at least 50% receive adjuvant chemotherapy as outlined below. patients undergoing limb-sparing wide excision receive post-operative radiotherapy as outlined below. adjuvant chemotherapy: beginning 3-4 weeks after surgery, patients receive cisplatin iv over 4 hours on day 1 and doxorubicin as above on days 1-3. treatment continues every 3 weeks for 4 courses in the absence of disease progression, stable disease, or unacceptable toxicity. patients undergoing radiotherapy receive the final 3 courses of chemotherapy after completion of radiotherapy. post-operative radiotherapy: beginning after the first postoperative chemotherapy course and within 8 weeks after surgery, patients receive radiotherapy 5 days a week for 7-8 weeks. an interstitial implant using iridium ir 192 may be used to administer the final doses of radiotherapy. projected accrual: a total of 40 patients will be accrued for this study within 4 years.

Eligibility criteria:
disease characteristics: diagnosis of intermediate- or high-grade soft tissue sarcoma of the extremity amenable to limb-sparing procedure or amputation buttocks or shoulder lesions allowed if an artery is available for cannulation no metastasis patient characteristics: age: 18 and over performance status: not specified life expectancy: not specified hematopoietic: wbc at least 3,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 2.0 mg/dl renal: creatinine clearance at least 60 ml/min cardiovascular: ejection fraction at least 50% by muga scan no history of congestive heart failure or severe angina pectoris other: no other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix not pregnant fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy surgery: see disease characteristics

Keywords: stage i adult soft tissue sarcoma stage ii adult soft tissue sarcoma stage iii adult soft tissue sarcoma