Caphosol in Sarcoma Patients With Mucositis

Completed · Phase 2

Conditions studied: Sarcoma, Oral Mucositis

In brief

The goal of this clinical research study is to find out if Caphosol® (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 Caphosol® (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).

Key facts

Study ID

NCT00965172

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2010-04-01

Expected to finish

2012-02-01

Last updated by the study team

2012-03-22

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with high dose doxorubicin (75-90 mg/m\^2) with ifosfamide (AI) or cisplatin (AP) is indicated.
• Must be >16 and < 65 years of age.
• Females of childbearing potential (defined as not post-menopausal for 12 months, or no previous surgical sterilization) must have a negative blood pregnancy test.
• Male and Females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, us of a intrauterine device (IUD) or abstinence.
• Adequate hematologic (ANC > 1500/mm\^3, platelet count > 150,000/mm\^3), renal (serum creatinine < 1.5mg/dL), hepatic (serum bilirubin count < 1.5 x normal and SGPT <3 x normal) functions.
• Karnofsky Performance Status >/= 80%
• Signed informed consent form.

You may not qualify if…

• Pregnant or lactating women.
• Patients with any co-morbid condition which renders patients at high risk of treatment complication.
• Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or hypertension, acute myocardial infarction within 3 months
• Patient has an active seizure disorder. (Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years.)
• Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
• Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.

Where it is running

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

Full record on ClinicalTrials.gov

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