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Phase2 study of palonosetoron and dexamethasone therapy for prevention of carboplatin-induced nausea and vomiting in patients with gynecological cancer.

Phase2 study of palonosetoron and dexamethasone therapy for prevention of carboplatin-induced nausea and vomiting in patients with gynecological cancer. - Phase2 study of palonosetoron and dexamethasone therapy for prevention of carboplatin-induced nausea and vomiting in patients with gynecological cancer.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012806
Enrollment
80
Registered
2014-01-09
Start date
2014-01-20
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

gynecological cancer (ovarian cancer, endometrial cancer and uterine cervix cancer)

Interventions

Palonosetron 0.75mg iv. prior to chemotherapy on Day1. Dexamethasone Day1 19.8mg or 9.9 mg iv. prior to chemotherapy. Day2 8.0mg orally or 6.6mg iv. Day3 8.0mg orally or 6.6mg iv.

Sponsors

West Japan Gynecologic Oncology Group
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1 more than Age 20 2 Patients with histologically proven gynecological cancer 3 No prior chemotherapy 4 Patient receiving carboplatin AUC5 6 5 Patient have enough organ function based on blood test within 8 days before registration Neutrophils more than 2,000 Platelets more than 100,000 AST and ALT less than 100 Serum creatinine less than1.5 6 ECOG performance status 0 2 7 Written informed consent

Exclusion criteria

Exclusion criteria: 1 Uncontrolled severe complication disease without cancers 2 Symptomatic brain metastasis 3 Epilepsy patient treated with antiepileptic agent, excluding being 4 Patient with massive pleural effusion or ascites to be required drainage 5 Intestinal paralysis or ileus 6 Grade 2 or more nausea and vomiting 7 Hypersensitivity for palonosetron and other 5 HT3 antagonist 8 Hypersensitivity for dexamethasone 9 Pregnant ,lactating woman or women who do not agree that we prevent conception 10 Patient with history of palonosetoron treatment 11 Patient without compliance of this study rule 12 Other patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

MeasureTime frame
Complete control rate during the delay phase

Countries

Japan

Contacts

Public ContactKimio Ushijima

Kurume University School of Medicine Department of Obstetrics and Gynecology

kimi@med.kurume-u.ac.jp0942-31-7573

Outcome results

None listed

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