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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma  Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
For Condition: stage 2 adult soft tissue sarcoma,stage 3 adult soft tissue sarcoma,stage 1 adult soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): Sylvester Cancer Center ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: See Disease Characteristics --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PasqualeBenedetto, Study Chair, Sylvester Cancer Center
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Additional Information:
Study ID Numbers: CDR0000077561; SCCC-89032,NCI-V92-0066
Study Start Date: November 1991
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002492
Other Stage 2 Adult Soft Tissue Sarcoma Studies:
1. Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
Related Studies:
Other stage 2 adult soft tissue sarcoma Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
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