MDACC Study Summary 2008-0276 (Archived)

Study Summary
No. 2008-0276:.......Sarcoma......Saroj Vadhan-Raj......Cytokines and Supportive Care

Study Summary Title



Study Summary Number:	2008-0276

Study 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

Physician

New Patient Referral



Name:	Saroj Vadhan-Raj	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Cytokines and Supportive Care	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-9660 Contact us about clinical trials

General Information



Disease Group:	Sarcoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Around every 3 weeks for chemotherapy and 2-3 times for oral assessment during each cycle

Treatment Agents:	Cisplatin Doxorubicin Filgrastim Ifosfamide Palifermin Pegfilgrastim Sodium Bicarbonate	Home Care:	supportive care

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

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).

Study Objectives / Outcomes

1.0 OBJECTIVES
Primary Objectives:
1) To evaluate the preliminary efficacy of calcium phosphate solution compared to standard baking soda oral rinse in reducing the incidence and severity of oral mucositis in patients with sarcoma receiving multi-cycle chemotherapy.
2) To evaluate the safety profile of calcium phosphate solution in patients receiving multi-cycle chemotherapy.

Exploratory Objectives:
1) To evaluate the biologic effect of calcium phosphate solution on oral mucosa.
2) To measure the levels of pro-inflammatory cytokines and other biomarkers in the blood, serum/plasma or saliva.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	04/07/2010

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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.

2) Must be >16 and < 65 years of age.

3) Females of childbearing potential (defined as not post-menopausal for 12 months, or no previous surgical sterilization) must have a negative blood pregnancy test.

4) 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 abstienence.

5) 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.

6) Karnofsky Performance Status >/= 80%

7) Signed informed consent form.

Exclusion Criteria:

1) Pregnant or lactating women.

2) Patients with any co-morbid condition which renders patients at high risk of treatment complication.

3) 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

4) 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.)

5) Prior surgery or radiotherapy (RT) within 2 weeks of study entry.

6) Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.

Links

Registration Number: NCT00965172
Study Information on Clinical Trials Registry (clinicaltrials.gov)