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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


Phase 2
16 Years
65 Years
Not Enrolling
Both
Sarcoma, Oral Mucositis

Thank you

Trial Information

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


Chemotherapy and radiation therapy can hurt normal cells in the gastrointestinal tract
(which includes the mouth and intestines). When this happens, it can cause mucositis
(inflammation of the lining of the mouth, throat, and intestines). Researchers want to
compare the effects of calcium phosphate and baking soda on patients who are at risk for
mucositis.

The Study Drugs:

Caphosol (calcium phosphate) is a saliva-like liquid that is designed to replace the
chemical and pH (acid) balance in the mouth. It is used as a mouth rinse to moisten,
lubricate, and clean the mouth, including the lining of the mouth, tongue, and throat. It
is also used to loosen thick mucous and help prevent the mucous membranes from sticking
together.

Baking soda is used as the standard of care for preventing and treating mucositis.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to receive either calcium phosphate mouth rinse or the baking
soda mouth rinse during the study. There is an equal chance of being assigned to either
group.

You will use the mouth rinse 5 times every day. The study staff will explain how to mix and
rinse with it.

Calcium phosphate should be stored at room temperature and should not be refrigerated. If
you are on a low sodium diet, you should check with your doctor before using calcium
phosphate.

Baseline Tests:

The following tests and procedures will be performed before you receive your first dose of
chemotherapy:

- Blood (about 3 teaspoons) will be drawn for routine tests.

- The mucous membranes in your mouth will be checked.

- You will be asked to complete a questionnaire (about 15 minutes) on how you feel.

- You will be given a diary before you start each cycle to record if you have any mouth
pain.

Study Tests:

You will need to come to MD Anderson on around Days 10, 12, and 14 (depending on the status
of the mucositis) of each chemotherapy cycle. During these clinic visits, the following
tests and procedures may be performed:

- You will have a physical exam, including measurement of your vital signs and weight.

- Blood (about 3 teaspoons) will be drawn for routine tests.

- The mucous membranes in your mouth will be checked. Also, you may have your mouth and
throat photographed.

- You will be asked to complete the questionnaire on how you feel.

- When possible, the optical imaging procedures will also be performed on these days.

Length of Study and Reasons for Leaving the Study Early:

You will take part in this study for up to 18 weeks (4 to 5 months). You will be taken off
study if you experience intolerable side effects.

End of Study Visit:

You will also have an end of study visit after you complete 6 cycles of study drug, if you
are taken off study for any reason, or if you choose to leave the study. During this visit,
the following tests and procedures will be performed:

- You will have a physical exam, including measurement of your vital signs and weight.

- Blood (about 3 teaspoons) will be drawn for routine tests.

- The mucous membranes in your mouth will be checked.

- You will be asked to complete the questionnaire on how you feel.

- You will receive a phone call from the nurse after you last dose of study drug to
follow up on any side effects.

This is an investigational study. Caphosol (calcium phosphate) is FDA approved and
commercially available for use in preventing and treating mucositis, and for relief of dry
mouth during high dose chemotherapy or radiation treatment.

Up to 30 patients will take part in this study. All will be enrolled at M. D Anderson.


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 abstinence.

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence/Severity of Oral Mucositis WHO Grades 1, 2, 3, and 4

Outcome Time Frame:

Incidence of mucositis (all grades) within 6 cycles of treatment (estimate 18 weeks, 4 to 5 months).

Safety Issue:

No

Principal Investigator

Saroj Vadhan-Raj, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0276

NCT ID:

NCT00965172

Start Date:

April 2010

Completion Date:

February 2012

Related Keywords:

  • Sarcoma
  • Oral Mucositis
  • Cancer
  • Mucositis
  • Chemotherapy
  • Caphosol
  • Calcium phosphate
  • Sodium Bicarbonate
  • Baking Soda Solution
  • Multi-cycle chemotherapy
  • Stomatitis
  • Mucositis
  • Sarcoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030