Study of efficacy and tolerability of combination therapy with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with cervical cancer.

Study of efficacy and tolerability of combination therapy with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with cervical cancer. - Study of efficacy and tolerability of combination therapy with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with cervical cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004962

Enrollment

Registered

2011-02-01

Start date

2011-02-01

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

Cervical cancer

Interventions

palonosetron 0.75mg (day 1) (iv)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: # 20 Years and older # Cervical cancer # Patients with received the combination therapy with nedaplatin and irinotecan # Adequate organ function for enrollment # Performance Status : 0-2 # Patients with written informed consent

Exclusion criteria

Exclusion criteria: # They had serious complication. (intestinal paralysis, lung fibrosis, diabetes mellitus, heart failure, myocardial infarction, angina pectoris, renal failure, psychiatric disorder, cerebrovascular accident, active gastric ulcer, active duodenal ulcer) # No known CNS metastasis # Patients who has a convulsive disorders that need anticonvulsants therapy # They had ascites or pleural effusion needs paracentesis treatment # Patients with obstruction of gastrointestinal tract,for example gastric outlet or ileus # Patients with vomiting or nausea (>= Grade2) # Hypersensitivity or severe drug allergy for Aloxi or other 5-HT3RA # Hypersensitivity or severe drug allergy for dexamethasone # Pregnant, breastfeeding or expecting woman # Patients judged inappropriate for this study by physicians

Design outcomes

Primary

Measure	Time frame
The proportion of patients with complete response (CR: no vomiting and no use of rescue therapy ) in the delayed phase (24-120 hour after administration of nedaplatin and irinotecan)	—

Countries

Japan

Contacts

Public ContactMasafumi Koshiyama

Kyoto University Graduate School of Medicine Gynecology and Obstetrics

babatsu@kuhp.kyoto-u.ac.jp0757513269

Outcome results

None listed

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