drugset
drugset / Trial / NCT00673179

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

NCT00673179 ↗

Terminated 7 enrolled M.D. Anderson Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-05
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 60 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 120 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 90 mg/m2 Intravenous
Subject Gemcitabine Small molecule — Intravenous
Subject Ifosfamide Small molecule 2800 mg/m2 Intravenous
Subject Methotrexate Small molecule 12000 mg/m2 Intravenous
Subject sargramostim Protein / enzyme biologic 5 ug/kg Inhaled
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 2800 mg/m2 Intravenous
Background Dexrazoxane Small molecule 900 mg/m2 Intravenous
Background Leucovorin Small molecule 10 mg Intravenous

Indications

osteosarcoma