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

Stopped early · Not applicable

Conditions studied: Osteosarcoma

In brief

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.

Key facts

Study ID

NCT00673179

Run by

M.D. Anderson Cancer Center

People needed

7

Starts

2008-05-01

Expected to finish

2010-11-01

Last updated by the study team

2014-09-10

Who can join

Age: 5 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed high-grade osteosarcoma. Patients with unresectable or metastatic disease ARE eligible.
• Age 5-40 years old on date of diagnostic biopsy.
• 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.
• Signed informed consent.
• Negative pregnancy test in females of child bearing potential, and if sexually active, willingness to use effective contraception during chemotherapy.

You may not qualify if…

• Diagnosis other than osteosarcoma.
• Pregnant or lactating females, or unwilling to use effective contraception during chemotherapy

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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