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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-1989032 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center | |
| NCI-V92-0066 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| isolated limb perfusion | Drug | |||
| conventional surgery | Procedure | |||
| brachytherapy | Radiation | |||
| radiation therapy | Radiation |
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
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| Name | Affiliation | Role |
|---|---|---|
| Pasquale W. Benedetto, MD | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sylvester Cancer Center, University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D004317 | Doxorubicin |
| D001918 | Brachytherapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| D003630 |
| Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |