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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00687011
• Date of registration: 27/05/2008
• Primary sponsor: Schering-Plough
• Public title: Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)(COMPLETED)
• Scientific title: Open-label Clinical Trial to Assess the Efficacy, Tolerability and Safety of a Single IV Dose of Palonosetron 0.25 mg + Dexamethasone IV in the Prevention of Moderately Emetogenic Chemotherapy-induced Nausea and Vomit (CINV).
• Date of first enrolment: January 2008
• Target sample size: 110
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00687011
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Mexico

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Nausea

Neoplasms

Vomiting

Intervention(s)

Drug: Palonosetron and Dexamethasone

Primary Outcome(s)

Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication. [Time Frame: During 24 hours after administration of chemotherapy.]

Secondary Outcome(s)

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 [Time Frame: Days 1 to 5 at different time intervals for each secondary outcome.]

Severity of nausea; Patient global satisfaction; Quality of life questionnaire [Time Frame: Days 1 to 5 at different time intervals for each secondary outcome.]

Secondary ID(s)

P04594

Source(s) of Monetary Support

Please refer to primary and secondary sponsors