CLINICAL AND PHARMACOLOGICAL STUDY OF CHEMOTHERAPY IN 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.
Primary Purpose: Treatment
Pasquale W. Benedetto, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|Sylvester Cancer Center, University of Miami||Miami, Florida 33136|