Netupitant and Palonosetron Hydrochloride in Treating Participants with Refractory Chemotherapy-Induced Nausea and Vomiting
This phase II trial studies how well netupitant and palonosetron hydrochloride work in treating participants with chemotherapy-induced nausea and vomiting that does not respond to treatment. Netupitant and palonosetron hydrochloride may reduce the nausea and vomiting caused by chemotherapy.
Inclusion Criteria
- Must have a histologically confirmed cancer diagnosis
- Must have refractory CINV defined as nausea and/or vomiting that occurs after the first cycle of cancer targeted therapy despite guideline-based prophylaxis and after first-line rescue medication with either a dopamine receptor antagonist, steroid, and/or benzodiazepine
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Life expectancy greater than 3 months
- Corrected serum calcium level less than or equal to 10.5 mg/dL
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 14 days following completion of therapy; a woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months)
- Women of child-bearing potential must have a negative pregnancy test prior to initiating study treatment
- Ability to understand and willingness to sign a written informed consent
Exclusion Criteria
- Patients with corrected QT (QTc) interval greater than 450 ms
- Patients with a known hypersensitivity reaction to 5-HT3 receptor antagonists or NK1 receptor antagonists
- Patients who have taken any medication classified as a strong CYP3A4 inducer within one week of study day 1 or 5 half-lives (whichever is longer) or use of a strong or moderate CYP3A4 inhibitor within one week of study day 1 or 5 half-lives (whichever is longer)
- Patients with severe hepatic impairment as defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than three times the upper limit of normal and/or, total bilirubin greater than 3 mg/dL, and/or Child-Pugh score > 9
- Patients with severe renal impairment defined as creatinine clearance of 15-29 mL/min and/or diagnosed with stage 4 chronic kidney disease
- Patients with end-stage renal disease defined as creatinine clearance of < 15mL/min and/or diagnosed with stage 5 chronic kidney disease
- Pregnant or lactating females are excluded from enrollment on this trial
- Patients unable to swallow oral medications
- Any other condition that, in the opinion of the investigator, may impact the absorption of oral medications
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03008213.
PRIMARY OBJECTIVES:
I. To determine the feasibility of using a fixed dose combination of netupitant and palonosetron hydrochloride (palonosetron) (Akynzeo) in the treatment of refractory chemotherapy-induced nausea and vomiting (CINV).
SECONDARY OBJECTIVES:
I. To evaluate the occurrence of adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
II. To evaluate complete response defined as no emesis and no use of rescue medication for 5 days after Akynzeo administration.
III. To characterize 24-hour CINV using a modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
IV. To evaluate 5-day health related quality of life recall using the Functional Living Index for Emesis (FLIE) scale.
V. To evaluate healthcare resource utilization as defined by the number of emergency room visits, hospitalizations, and infusion center visits encounters regarding signs/symptoms associated with CINV over the seven-day study period.
VI. To evaluate the occurrence of refractory CINV using CINV risk assessment at follow up day 7 compared to treatment day 1.
EXPLORATORY OBJECTIVES:
I. To determine patient preference for use of Akynzeo for future planned chemotherapy utilizing a five-point Likert scale.
OUTLINE:
Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on day 1.
After completion of study treatment, participants are followed up for 7 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUC San Diego Medical Center - Hillcrest
Principal InvestigatorEric Roeland
- Primary ID161691
- Secondary IDsNCI-2018-00249
- ClinicalTrials.gov IDNCT03008213