Status:
TERMINATED
Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Osteosarcoma
Eligibility:
All Genders
5-40 years
Phase:
NA
Brief 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 resu...
Detailed Description
The Study Drugs: The standard treatment combination used to treat patients with osteosarcoma is doxorubicin, cisplatin, and methotrexate with or without ifosfamide. When this treatment combination is...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Diagnosis other than osteosarcoma.
- Pregnant or lactating females, or unwilling to use effective contraception during chemotherapy
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00673179
Start Date
May 1 2008
End Date
November 1 2010
Last Update
September 10 2014
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030