Overview

Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
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. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase III trial to study the effectiveness of three combination chemotherapy regimens plus dexrazoxane in treating patients who have newly diagnosed nonmetastatic osteosarcoma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cisplatin
Dexrazoxane
Doxorubicin
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Methotrexate
Razoxane
Criteria
DISEASE CHARACTERISTICS: Histologically proven newly diagnosed moderate or high grade
osteosarcoma without metastases No prior treatment, including complete resection No
parosteal or periosteal sarcoma No osteosarcoma associated with Paget's disease No
nonresectable tumors or tumors that may result in marginal or interlesion resection Must be
enrolled on protocol POG-9851

PATIENT CHARACTERISTICS: Age: 30 and under Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than
3 times normal Renal: Creatinine normal Phosphate at least 3.0 mg/dL without
supplementation Cardiovascular: Shortening fraction at least 28% by echocardiogram If
echocardiogram unsatisfactory, must have ejection fraction at least 50% No history of
pericarditis or myocarditis No symptomatic arrhythmia or symptomatic cardiac conduction
disturbances

PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: Not specified
Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy Surgery: See Disease Characteristics