Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)

NCT00687011 | Completed Phase 4

• 1 other identifier: P04594
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if a single intravenous (IV) dose of palonosetron 0.25 mg plus a single IV dose of dexamethasone 8 mg is effective to prevent nausea and vomiting induced by moderately emetogenic chemotherapy in subjects with cancer.

Conditions

Neoplasms; Nausea; Vomiting

Keywords

Antiemetic

Outcome Measures

Primary Outcomes (1)

• Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.

  During 24 hours after administration of chemotherapy.

Secondary Outcomes (2)

• Proportion of patients who achieved a CR and of those who achieved complete control; Number of emetic episodes; Time to first emetic episode, to administration and need for rescue therapy; and to treatment failure

  Days 1 to 5 at different time intervals for each secondary outcome.

• Severity of nausea; Patient global satisfaction; Quality of life questionnaire

  Days 1 to 5 at different time intervals for each secondary outcome.

Study Arms (1)

Palonosetron-dexamethasone

EXPERIMENTAL

Drug: Palonosetron and Dexamethasone

Interventions

Palonosetron and Dexamethasone DRUG

0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent, plus single IV dose of dexamethasone 8 mg administered 15 minutes before chemotherapy (in the event of a shortage of IV dexamethasone, a single oral dose of dexamethasone 20 mg or a single IV dose of methylprednisolone 125 mg could be administered).

Also known as: SCH 734291

Palonosetron-dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, \>= 18 years of age.
• Histologically or cytologically confirmed malignant disease.
• Naive or non-naive to chemotherapy.
• Karnofsky index \>= 70%.
• Scheduled to receive a single dose of at least one of the following agents administered on Study Day 1: any dose of Dactynomicin, Carboplatin, Epirubicin, Idarubicin, Ifosfamide, Irinotecan, Lomustine; or Methotrexate \>250 mg/m\^2, or Cyclophosphamide \<=1500 mg/m\^2, or Mitoxantrone \<15 mg/m\^2, or Doxorubicin \>= 20 mg/m\^2, or Citarabin \> 1g/m\^2, Melphalan \> 50 mg/m\^2 , oxaliplatin \> 75 mg/m\^2 administered over 1 to 4 hours. The administration of the major chemotherapeutic agent (which is the most emetogenic agent according to the classification of Hesketh, et al., The Oncologist 1999, 4: 191-196) defined Study Day 1 and administration of this agent should not extend beyond 4 hours.
• Provided signed written informed consent.
• Females of childbearing potential must be using reliable contraceptive measures with a negative pregnancy test at the pre-treatment visit.
• If a patient had a known hepatic, renal or cardiovascular impairment and is scheduled to receive the above mentioned chemotherapeutic agents, he/she could be enrolled in this study at the discretion of the investigator.
• If a patient had experienced at maximum mild nausea following any previous chemotherapy regimen, he/she could be enrolled in this study at the discretion of the investigator.

You may not qualify if:

• Unable to understand or cooperate with the study procedures.
• Received any investigational drugs within 30 days before study entry.
• Received any drug with potential anti-emetic efficacy within 24 hours of the start of treatment or will be scheduled to receive until Study Day 5 including 5-HT3 receptor antagonists, metoclopramide, phenothiazine anti-emetics (including prochlorperazine, thiethylperazine and perphenazine), scopolamine, diphenhydramine, chlorpheniramine maleate, trimethobenzamide, all benzodiazepines except temazepam or triazolam used once nightly for sleep, haloperidol, droperidol, tetrahydrocannabinol, or nabilone, any corticosteroid including dexamethasone, hydrocortisone, methylprednisolone, prednisone (excluding topical or inhaled preparations).
• Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
• Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy.
• Ongoing vomiting from any organic etiology.
• Experienced nausea (moderate or severe) or vomiting following any previous chemotherapy. At the discretion of the investigator, a patient who experienced at maximum mild nausea following any previous chemotherapy might not be excluded from this study.
• Scheduled to receive any dose of cisplatin, carmustine, hexametilamine, dacarbazine, Mecloretamine, Streptozotocin, Procarbazine o Cyclophosphamide \> 1500 mg/m\^2 or any other chemotherapeutic agent with an emetogenicity level 5 according to the classification of NCCN Guidelines v1 2005 during Study Days 2-6.
• Known contraindication to 5-HT3 receptor antagonists.
• Scheduled to receive radiotherapy of the upper abdomen or cranium during Study Day 2-6.
• QTc \> 500 msec at baseline.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Neoplasms; Nausea; Vomiting

Interventions

Palonosetron; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: October 10, 2006
• Primary Completion: October 27, 2008
• Study Completion: October 27, 2008
• Last Updated: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share