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Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer.

Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer. - Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008629
Enrollment
45
Registered
2012-08-06
Start date
2011-06-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial cancer

Interventions

Palonosetron: day1 0.75mg (i.v.) Aprepitant: day1 125mg, 2-3 80mg (p.o.) Dexamethasone: day1 9.9mg (i.v.)

Sponsors

Urology, Department of Medicine Kitasato University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who need anticonvulsants therapy 2) Vomiting, or CTCAE grade 2 or higher nausea 3) History of hypersensitivity for Palonosetron and/or Aprepitant and/or Dexamethasone 4) Pregnant or lactating women or women of childbearing potential 5) Receiving medicine that has antiemetic activity 6) Patient who doesn't have ability or intention that cooperates for procedure of the study 7) Not appropriate for the study at the physician's assessment

Exclusion criteria

Exclusion criteria: 1) Patients who need anticonvulsants therapy 2) Vomiting, or CTCAE grade 2 or higher nausea 3) History of hypersensitivity for Palonosetron and/or Aprepitant and/or Dexamethasone 4) Pregnant or lactating women or women of childbearing potential 5) Receiving medicine that has antiemetic activity 6) Patient who doesn't have ability or intention that cooperates for procedure of the study 7) Not appropriate for the study at the physician's assessment

Design outcomes

Primary

MeasureTime frame
Complete Response Rate in overall phase(0-120 hours after chemotherapy)

Secondary

MeasureTime frame
Complete Response Rate in acute and delayed phase Complete Control Rate in overall, acute and delayed phase The proportion of patients without nausea in overall, acute and delayed phase Safety

Countries

Japan

Contacts

Public ContactKazumasa Matsumoto

Department of Medicine Kitasato University, School of Medicine Urology

kazumasa@cd5.so-net.ne.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026