NCT02732015

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Sarcoma

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given IV
DRUG	Doxorubicin	Given IV
DRUG	Fosaprepitant Dimeglumine	Given IV
DRUG	Ifosfamide	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Mesna	Given IV
DRUG	Ondansetron	Given IV
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Rolapitant Hydrochloride	Given PO
DRUG	Vincristine Sulfate	Given IV

Timeline

• Start date: 2016-10-12
• Primary completion: 2020-07-10
• Completion: 2020-07-10
• First posted: 2016-04-08
• Last updated: 2021-08-09
• Results posted: 2021-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study