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Evaluation of Fosaprepitant's Effect on Drug Metabolism in Sarcoma Patients Receiving Ifosfamide-based Multi-day Chemotherapy Regimen


N/A
18 Years
65 Years
Open (Enrolling)
Both
Sarcoma, Chemotherapy-induced Nausea and Vomiting, Effects of Chemotherapy, Adverse Effects of Medical Drugs

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Trial Information

Evaluation of Fosaprepitant's Effect on Drug Metabolism in Sarcoma Patients Receiving Ifosfamide-based Multi-day Chemotherapy Regimen


Study Groups:

If you are found to be eligible to take part in this study, you will receive fosaprepitant
during 21-day chemotherapy cycles. You will be randomly assigned (as in a toss of dice) to
1 of 2 study groups, each with 2 divisions:

- If you are in Group A1, you will receive fosaprepitant on Day 1 of Cycle 1.

- If you are in Group A2, you will receive fosaprepitant on Day 1 of Cycle 2.

- If you are in Group B1, you will receive fosaprepitant on Days 1 and 4 of Cycle 1.

- If you are in Group B2, you will receive fosaprepitant on Days 1 and 4 Cycle 2.

You and the study staff will know to which group and division you are assigned. Each time
you receive the drug, you will receive it by vein over about 20-30 minutes.

You will also receive the ifosfamide-based chemotherapy prescribed by your doctor, as well
as standard drugs for preventing nausea and vomiting (such as ondansetron, lorazepam,
diphenhydramine, and promethazine). You will sign a separate consent form that will
describe these treatments in detail, along with their risks.

You will receive dexamethasone before chemotherapy, every day for 5 days, to help prevent
nausea and vomiting.

Before each chemotherapy cycle, you will be given a study diary. Each day, you will record
any side effects you may . You should bring your study diary to every study visit so the
study staff can review it.

Study Visits:

Before each cycle that you receive fosaprepitant, the following tests and procedures will be
performed:

- You will have a physical exam.

- Your vital signs, weight, and performance status will be recorded.

- You will fill out the same questionnaire you did at screening.

- You will be asked about any other drugs you may be taking. Be sure to tell the study
doctor about all drugs (including vitamins, herbal products, and nutritional
supplements), because some drugs/substances will cause side effects when taken at the
same time as fosaprepitant.

- Blood (about 5 teaspoons) will be drawn for routine tests.

Blood (about 1 teaspoon) will also be drawn 2 times each week during Cycles 1 and 2 for
routine tests.

Pharmacokinetic Testing:

On Days 1 and 4 of Cycles 1 and 2 of chemotherapy, blood samples (about 2 teaspoons each
time) will be drawn for pharmacokinetic (PK) testing, when possible. PK testing measures
the amount of study drug in the body at different time points. The blood will be drawn
before you receive ifosfamide, at the end of the infusion, and 4 more times in the 24 hours
after the infusion.

Length of Study:

You may receive up to 6 cycles of chemotherapy (and up to 5 cycles of fosaprepitant). You
will no longer be able to take the study drug if the disease gets worse or if intolerable
side effects occur.

Your participation on the study will be over once you have completed the end-of-study visit.

End-of-Study Visit:

About 3 weeks after your last dose of fosaprepitant, you will return for an end-of-study
visit. At this visit, the following tests and procedures will be performed:

- You will have a physical exam.

- Your vital signs, weight, and performance status will be recorded.

- You will fill out the same questionnaire you did at screening.

- You will be asked about any other drugs you may be taking.

- Blood (about 5 teaspoons) will be drawn for routine tests.

This is an investigational study. Fosaprepitant is FDA approved and commercially available
in combination with other drugs for the prevention of nausea and vomiting that may be caused
by chemotherapy. It is investigational to study how fosaprepitant may affect the drug
levels of ifosfamide in the blood and how many doses should be given.

Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patients with sarcoma which is locally advanced, at high risk for relapse or
metastatic for whom treatment with doxorubicin plus ifosfamide (AI) or AI and
vincristine (VAI) is indicated.

2. Must be 18-65 years of age.

3. 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.

4. Adequate hematologic (ANC >/= 1500/mm^3, platelet count >/= 100,000/mm^3), renal
(serum creatinine SGOT or SGPT
5. Karnofsky Performance Status >/= 60%

6. Signed informed consent form.

7. Patients are required to read and understand English to comply with protocol
requirements.

Exclusion Criteria:

1. Pregnant or lactating women.

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

3. Known allergy to fosaprepitant or any of its active components.

4. Patient has uncontrolled angina, congestive heart failure (New York Heart Association
> class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or
hypertension, or acute myocardial infarction within 3 months.

5. 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).

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

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

8. Patients receiving any medication for pre-existing nausea/vomiting will be excluded.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Plasma Areas Under the Concentration Curve (AUC) of Ifosfamide

Outcome Description:

Effect of Fosaprepitant on Ifosfamide metabolism by pharmacokinetics (PK), Day 1 and Day 4 plasma AUC0-24s (area under curve during 24 hours) of ifosfamide. PK measures (AUC) for ifosfamide calculated for participants that complete 2 cycles of chemotherapy and PK blood collection. PK sampling during first 2 chemotherapy cycles, prior to chemotherapy infusion (baseline) and post-infusion (3 hour from initiation of ifosfamide), and 4 , 6, 8, and 24 hour time points from the initiation of ifosfamide infusion on day 1 and day 4 (last infusion of ifosfamide) in first 2 cycles for all patients.

Outcome Time Frame:

From Day 1 to Day 4 in two 21-days cycles

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:

2011-0620

NCT ID:

NCT01490060

Start Date:

May 2012

Completion Date:

Related Keywords:

  • Sarcoma
  • Chemotherapy-Induced Nausea and Vomiting
  • Effects of Chemotherapy
  • Adverse Effects of Medical Drugs
  • cancer
  • fosaprepitant
  • Ifosfamide-based Multi-day Chemotherapy
  • Chemotherapy-induced nausea and vomiting
  • CINV
  • multi-day chemotherapy regimens
  • antiemetics
  • adverse effect
  • doxorubicin plus ifosfamide
  • AI
  • AI and vincristine
  • VAI
  • aprepitant
  • prevention
  • nausea
  • vomiting
  • emetogenic chemotherapy
  • Nausea
  • Vomiting
  • Sarcoma

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030