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Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.

Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.

Fosaprepitant Dimeglumine

Laboratory Biomarker Analysis

Questionnaire Administration

Rolapitant Hydrochloride

Vincristine Sulfate

Saroj Vadhan

This randomized phase II trial studies how well rolapitant hydrochloride works in preventing nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated with chemotherapy.

PRIMARY OBJECTIVE:

I. To evaluate the effect of rolapitant hydrochloride (rolapitant) on nausea/vomiting in patients with sarcoma receiving multi-day highly emetogenic chemotherapy (HEC) regimen of doxorubicin and ifosfamide (AI).

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of rolapitant in patients receiving AI regimen. II. To evaluate the effects of rolapitant on patient reported outcomes.

OUTLINE:

PART I: Patients receive dexamethasone intravenously (IV) daily and ondansetron IV on days 1-5, and rolapitant hydrochloride orally (PO) on day 1.

PART II: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.

Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy

Effects of Rolapitant on Nausea/Vomiting in Patients With Sarcoma Receiving Multi-Day Highly Emetogenic Chemotherapy (HEC) With Doxorubicin and Ifosfamide Regimen (AI)

Complete response (CR) no emetic episodes and no rescue medications.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Dexamethasone IV daily for 5 days (12 mg on day 1 and 8 mg on days 2-5), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.

Cohort 1

Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1

Cohort 2

Cohort 1 - 8mg Dexamethasone

Cohort 2- 12mg Dexamethasone

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Saroj Vadhan,MD-Clinical Professor, Cytokine & Supportive Oncology

Dexamethasone IV daily for 5 days (12 mg on days 1-5 ), Ondansetron (5HT3 receptor antagonist) 16 mg IV daily for 5 days as standard of care, and Rolapitant, 180 mg was administered PO on Day 1.

Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose

Overall Study

Spots Global Cancer Trial Database for rolapitant hydrochloride