A Single-dose, multicenter, randomized study to assess the efficacy and safety of oral palonosetron ....... receiving a chemotherapy regimen which includes cisplatin.
- Conditions
- Health Condition 1: null- Prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving highly emetogenic cisplatin-based chemotherapy
- Registration Number
- CTRI/2011/10/002073
- Lead Sponsor
- Helsinn Healthcare SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 740
1.Male or female patient >=18 years of age.
2.Naive to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
3.Diagnosed with a malignant solid tumor and scheduled to receive first course of cytotoxic chemotherapy with cisplatin administered as a single I.V. dose of 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents ( If scheduled to receive combination regimens, non-cisplatin agents of moderate to high emetogenic potential are allowed and they must be administered following the cisplatin infusion and completed no more than 6 hours after the initiation of cisplatin infusion; If scheduled to receive chemotherapy agents of minimal to low emetogenic potential, they are to be given on Day 1 following cisplatin or on any subsequent study day).
4.ECOG Performance Status of 0, 1, or 2 (Appendix 4).
5.Hematologic and metabolic status adequate for receiving a highly emetogenic
6.cisplatin-based regimen.
7.Able to read, understand, follow the study procedure and complete patient diary.
1.If female, pregnant or lactating.
2.Current use of illicit drugs or current evidence of alcohol abuse.
3.Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC
4.from Day 2 to Day 5 following cisplatin administration.
5.Received or is scheduled to receive radiation therapy to the abdomen, or the pelvis within 1 week prior to Day 1 or between Days 1 to 5.
6.Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.
7.Symptomatic primary or metastatic CNS malignancy.
8.Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled medical conditions (other than malignancy) that, in the opinion of the investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting, CINV) or pose unwarranted risks in administering the study drugs to the patient.
9.Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone.
10.Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1. However topical and inhaled corticosteroids with a steroid dose of 10 mg of prednisone daily or its equivalent are permitted.
11.Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.
12.Any medication with known or potential antiemetic activity within 24 hours prior to Day 1
13.Any illness or condition that, in the opinion of the investigator, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient.
14.Concurrent medical condition that would preclude administration of dexamethasone for 4 days such as systemic fungal infection or uncontrolled diabetes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the non-inferiority of single dose oral palonosetron 0.50 mg versus single dose I.V. palonosetron 0.25 mg in terms of percentage of patients with complete response during the acute phase. <br/ ><br> <br/ ><br>Timepoint: 0-24 hrs
- Secondary Outcome Measures
Name Time Method delayed and overall phase;the proportion of patients with complete protection (no emetic episode, no rescue medication and no significant nausea) during the acute, delayed andoverall phase;the proportion of patients with total control (no emetic episode, no rescue medication and no nausea) during the acute, delayed and overall phase;Timepoint: 0-120 hours;the proportion of patients with complete response during the delayed and <br/ ><br>overall phase;the proportion of patients with no emesis during the acute, delayed and <br/ ><br>overall phase,the proportion of patients with no rescue medication during the acute, <br/ ><br>delayed and overall phase,the proportion of patients with no significant nausea (maximum VisualAnalogue Scale, VAS 25 mm) during the acute, delayed and overall phase;the proportion of patients with no nausea (maximum VAS 5 mm) during the acute,Timepoint: 0-120 hrs