Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if giving certain combinations of chemotherapy drugs before and after surgery, mostly in the outpatient clinic instead of in the hospital, can result in fewer hospital stays during treatment for osteosarcoma. The drugs and schedules will vary depending on the status of the cancer and its level of risk for spreading, but they will include combinations of doxorubicin (non-liposomal), cisplatin, methotrexate, and ifosfamide, as described below.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Carboplatin; Cisplatin; Dexrazoxane; Doxorubicin; Gemcitabine; Ifosfamide; Isophosphamide mustard; Leucovorin; Liposomal doxorubicin; Mesna; Methotrexate; Razoxane; Sargramostim

Criteria

Inclusion Criteria:

1. Newly diagnosed high-grade osteosarcoma. Patients with unresectable or metastatic disease ARE eligible.

2. Age 5-40 years old on date of diagnostic biopsy.

3. Adequate organ function: creatinine 1.6 or lower, bilirubin <2, Hemoglobin 8 gm/dL or greater, Absolute neutrophil count (ANC) 1000 or more, platelets 100,000 or more. Cardiac ejection fraction (EF) 50% or better, hearing threshold 40 dB at 4000 Hz or better.

4. Signed informed consent.

5. Negative pregnancy test in females of child bearing potential, and if sexually active, willingness to use effective contraception during chemotherapy.

Exclusion Criteria:

1. Diagnosis other than osteosarcoma.

2. Pregnant or lactating females, or unwilling to use effective contraception during chemotherapy