Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006348
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2000-10-04
Brief Title:
Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Randomized Double-Blind Placebo-Controlled Crossover Trial of Ondansetron in the Control of Chronic Nausea and Vomiting Not Due to Antineoplastic Therapy in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Antiemetic drugs such as ondansetron may help to reduce or prevent nausea and vomiting in patients with advanced cancer
PURPOSE This randomized phase III trial is studying how well ondansetron works compared to a placebo in treating patients with advanced cancer and chronic nausea and vomiting that is not caused by cancer therapy
PURPOSE This randomized phase III trial is studying how well ondansetron works compared to a placebo in treating patients with advanced cancer and chronic nausea and vomiting that is not caused by cancer therapy
Detailed Description:
OBJECTIVES I Compare the antiemetic effect of ondansetron vs placebo in patients with advanced cancer who suffer from chronic nausea and emesis that is not due to antineoplastic therapy ie chemotherapy radiotherapy immunotherapy biologic therapy II Determine the toxicity of ondansetron in these patients III Evaluate the use of other concurrent antiemetics in these patients when treated with this regimen
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to abdominal carcinomatosis yes vs no renal insufficiency creatinine less than 20 mgdL vs creatinine at least 20 mgdL type of cancer brain vs gastrointestinal vs other and narcotic use yes vs no Patients are randomized to one of two treatment arms Arm I Patients receive oral ondansetron twice daily on days 1-7 and oral placebo twice daily on days 8-14 in the absence of unacceptable toxicity Arm II Patients receive oral placebo twice daily on days 1-7 and oral ondansetron twice daily on days 8-14 in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 100 patients 50 per arm will be accrued for this study within 1 year
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to abdominal carcinomatosis yes vs no renal insufficiency creatinine less than 20 mgdL vs creatinine at least 20 mgdL type of cancer brain vs gastrointestinal vs other and narcotic use yes vs no Patients are randomized to one of two treatment arms Arm I Patients receive oral ondansetron twice daily on days 1-7 and oral placebo twice daily on days 8-14 in the absence of unacceptable toxicity Arm II Patients receive oral placebo twice daily on days 1-7 and oral ondansetron twice daily on days 8-14 in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 100 patients 50 per arm will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P00-0168 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068205 | REGISTRY | None | None |