EICHORCondition: Nausea and Vomiting · Unspecified Adult Solid Tumor, Protocol Specific · Sponsor: Heron Therapeutics
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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 chemotherapy for cancer.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Anniston Oncology, PC | Anniston, Alabama, United States | — |
| Palo Verde Hematology Oncology - Glendale | Glendale, Arizona, United States | — |
| Arizona Clinical Research Center, Incorporated | Tucson, Arizona, United States | — |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas, United States | — |
| Pacific Cancer Medical Center, Incorporated | Anaheim, California, United States | — |
| Southbay Oncology / Hematology Medical Group | Campbell, California, United States | — |
| Compassionate Cancer Care Medical Group Incorporated - Corona | Corona, California, United States | — |
| Compassionate Cancer Care Medical Group Incorporated - Fountain Valley | Fountain Valley, California, United States | — |
| Advanced Research Management Services, Incorporated | Los Angeles, California, United States | — |
| Kenmar Research Institute | Los Angeles, California, United States | — |
| Medical Oncology Care Associates - Orange | Orange, California, United States | — |
| Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut, United States | — |
+ 40 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT00343460