Status:
COMPLETED
APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Lead Sponsor:
Heron Therapeutics
Conditions:
Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief Summary
This randomized phase III trial is studying APF530 and dexamethasone to see how well they work compared with palonosetron and dexamethasone in preventing nausea and vomiting in patients receiving chem...
Detailed Description
OBJECTIVES: Primary * Compare the overall activity and effects of APF530 versus palonosetron hydrochloride in combination with dexamethasone for prophylaxis of acute- or delayed-onset, chemotherapy-...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant disease
- No head and neck cancer or upper gastrointestinal cancer
- Scheduled to receive a single day of moderately or highly emetogenic chemotherapy regimen (for ≤ 4 courses)
- Chemotherapy administration ≤ 4 hours
- Duration of each course ≤ 28 days
- Causing nausea and vomiting in 30-100% of patients if untreated according to Hesketh algorithm
- Must be able to receive standardized doses of dexamethasone for the prevention of emesis during study treatment
- No greater than mild nausea or any vomiting within 24 hours before beginning study treatment
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known allergy or hypersensitivity to other selective 5-HT3 receptor antagonists or local anesthetics
- QTc interval ≤ 500 ms
- No cardiac abnormality predisposing the patient to arrhythmia
- No psychological problem that, in the opinion of the investigator, is severe enough to preclude study participation
- No recent history (i.e., ≤ 1 year) of alcohol or drug abuse
- No concurrent condition that, in the opinion of the investigator, could affect assessment of study medication or interfere with the nausea/vomiting response (e.g., severe renal or hepatic impairment)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No radiotherapy 7 days prior to, during, and 5 days after completion of study treatment
- More than 7 days since prior chemotherapy
- More than 7 days since prior and no concurrent prohibited medications (e.g., CYP3A4 inhibitors or other antiemetic medications)
- More than 7 days since prior antinausea medications
- More than 30 days since prior treatment on an investigational trial
- No other concurrent corticosteroids or dexamethasone at a different dose than study treatment
- No concurrent use of APF530, palonosetron hydrochloride, or aprepitant as rescue medications
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
1428 Patients enrolled
Trial Details
Trial ID
NCT00343460
Start Date
June 1 2006
End Date
February 1 2009
Last Update
February 23 2017
Active Locations (52)
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1
Anniston Oncology, PC
Anniston, Alabama, United States, 36207
2
Palo Verde Hematology Oncology - Glendale
Glendale, Arizona, United States, 85304
3
Arizona Clinical Research Center, Incorporated
Tucson, Arizona, United States, 85715
4
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205