Multicenter, randomized, controlled study to compare palonosetron plus dexamethasone before chemotherapy administration versus the same regimen with dexamethasone continuing on Days 2 and 3 in preventing nausea and vomiting in patients with solid tumors treated with moderately emetogenic chemotherapy - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000644-13-IT

Enrollment

330

Registered

2006-10-03

Start date

2006-08-04

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Solid tumours Level: SOC Classification code 10029104

Interventions

Trade Name: ALOXI Pharmaceutical Form: Solution for infusion Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .25- Pharmaceutical Form: Emulsion for injection INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female, 18 years of age; Have histologically or cytologically confirmed solid tumor any stage ; Consecutive enrollment; Patients previously treated or not with chemotherapy; Have an ECOG performance status of 0-2; Be scheduled to receive a single intravenous dose of at least 1 of the moderately emetogenic agents according to the modified Hesketh classification reported in the Appendix 1 on Day 1; Provide written informed consent; If female of childbearing potential must be using reliable contraceptive measures; Acceptable hepatic function 2 times the upper limit of normal for liver transaminases and renal function creatinine 1.5 times the upper limit of normal ; Willing and able to complete the patient diary. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Highly emetogenic chemotherapy cisplatin, mechloretamine, streptozotocin, cyclophosphamide 1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine , or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the classification reported in the Appendix 2 ; Diagnosis of lymphoma, leukemia, or myeloma; High-dose chemotherapy; Have received any investigational drugs within 30 days before study entry; Have received any drug with potential anti-emetic efficacy with the exception of dexamethasone within 24 hours of treatment initiation; Scheduled to receive up to Day 5 after chemotherapy administration of any drug with potential antiemetic properties; Prior treatment with palonosetron; Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity; Experienced vomiting or nausea in the screening phase; Brain metastases; Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis; Clinically relevant fluid and electrolyte abnormalities; Have a known hypersensitivity to 5HT3 receptor antagonists; Radiotherapy within 30 days before chemotherapy administration, or scheduled to receive radiotherapy within two weeks after chemotherapy; Female patients who are pregnant or breast feeding; Inability to understand or cooperate with the study procedures; Have ongoing vomiting from any organic etiology.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary end point is the overall rate of patients achieving a complete response defined as no emetic episode and no use of rescue medication during the whole study period the first 5 days following administration of the first cycle of chemotherapy .;Secondary Objective: Secondary end points, evaluated during the Acute Phase within the first 24 h after chemotherapy and during the Delayed Phase 24-120 h separately on single days and over the whole study period, include the following the rate of Complete Response; the rate of Complete Control defined as no emetic episode, and no need for rescue medication, with a maximum grade of mild nausea ; number of emetic episodes; severity of nausea graded according to NCI-CTC version 3; time to treatment failure first emetic episode or first need of rescue medication, whichever occurs first ; patient global satisfaction with antiemetic therapy, as measured by a visual analog scale VAS ; and safety.;Primary end point(s): The primary end point is the overall rate of patients achieving a complete response defined as no emetic episode and no use of rescue medication during the whole study period the first 5 days following administration of the first cycle of chemotherapy .	—

Measure

Time frame

Main Objective: The primary end point is the overall rate of patients achieving a complete response defined as no emetic episode and no use of rescue medication during the whole study period the first 5 days following administration of the first cycle of chemotherapy .;Secondary Objective: Secondary end points, evaluated during the Acute Phase within the first 24 h after chemotherapy and during the Delayed Phase 24-120 h separately on single days and over the whole study period, include the following the rate of Complete Response; the rate of Complete Control defined as no emetic episode, and no need for rescue medication, with a maximum grade of mild nausea ; number of emetic episodes; severity of nausea graded according to NCI-CTC version 3; time to treatment failure first emetic episode or first need of rescue medication, whichever occurs first ; patient global satisfaction with antiemetic therapy, as measured by a visual analog scale VAS ; and safety.;Primary end point(s): The primary end point is the overall rate of patients achieving a complete response defined as no emetic episode and no use of rescue medication during the whole study period the first 5 days following administration of the first cycle of chemotherapy .

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026