CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0276 (clinicaltrials.gov NCT No: NCT00965172)
Title:A Phase II study to evaluate the preliminary efficacy assessment of Caphosol in patients with sarcoma receiving multicycle chemotherapy with doxorubicin and ifosfamide or cisplatin
Principal Investigator:Saroj Vadhan-Raj
Treatment Agent:Cisplatin; Doxorubicin; Filgrastim; Ifosfamide; Palifermin; Pegfilgrastim; Sodium Bicarbonate
Study Status:Terminated
Study Description:The goal of this clinical research study is to find out if CaphosolŪ (calcium
phosphate) mouthwash is more effective than a baking soda solution at
preventing and treating mucositis, in patients with sarcoma who are to be
treated with chemotherapy. The safety of this drug will also be studied.
Researchers also want to learn about the way calcium phosphate may affect
mucous membranes.

The goal of this clinical research study is to see if CaphosolŪ (calcium
phosphate) mouthwash is better than baking soda solution in patients with
sarcoma who are to be treated with chemotherapy . Caphosol will also be
studied to see if it lessens the incidence and severity of oral mucositis
(painful sores in the mouth).

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Disease Group:Sarcoma
Phase of Study:Phase II
Treatment Agents:Cisplatin
Doxorubicin
Filgrastim
Ifosfamide
Palifermin
Pegfilgrastim
Sodium Bicarbonate
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:N/A
Supported By:N/A
Return Visit:Around every 3 weeks for chemotherapy and 2-3 times for oral assessment during
each cycle
Home Care:supportive care


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Physician Name:Saroj Vadhan-Raj
Dept:Cytokines and Supportive Care
For Clinical Trial Enrollment:713-792-9660
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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