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CLINICAL AND PHARMACOLOGICAL STUDY OF CHEMOTHERAPY IN SOFT TISSUE SARCOMA


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Pasquale W. Benedetto, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-89253

NCT ID:

NCT00002492

Start Date:

November 1991

Completion Date:

February 2000

Related Keywords:

  • Sarcoma
  • stage I adult soft tissue sarcoma
  • stage II adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • Sarcoma

Name

Location

Sylvester Cancer Center, University of MiamiMiami, Florida  33136