APF530 or Palonosetron Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Summary
RATIONALE: Antiemetic drugs, such as APF530, palonosetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients receiving chemotherapy for cancer. It is not yet known whether APF530 is more effective than palonosetron when given together with dexamethasone in preventing nausea and vomiting caused by chemotherapy.
PURPOSE: 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.
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-induced nausea and vomiting in patients undergoing moderately or highly emetogenic chemotherapy for cancer.
Secondary
- Evaluate the safety, tolerability, and efficacy of APF530, in terms of prevention of acute- and delayed-onset nausea and vomiting, in these patients.
- Gather the pharmacokinetics of APF530 in a subset of patients during chemotherapy course 1.
- Gather ECG data (using 24-hour Holter monitoring) in a subset of patients during chemotherapy course 1.
OUTLINE: This is a randomized, placebo-controlled, double-blind, parallel-group, multicenter study. Patients are stratified according to emetogenicity of scheduled chemotherapy (moderate-risk [level 3 or 4] vs high-risk [level 5]). Patients are randomized to 1 of 3 treatment arms (I, II, and III). Patients who are randomized to receive palonosetron hydrochloride during chemotherapy course 1 (arm I) are then re-randomized to 1 of 2 treatment arms (II and III) after chemotherapy course 1 to receive treatment during chemotherapy courses 2-4.
Patients receive palonosetron hydrochloride or APF530 and/or placebo 30-60 minutes before the start of chemotherapy. Patients receive dexamethasone 30-90 minutes before the start of chemotherapy.
- Arm I: Patients receive palonosetron hydrochloride IV, placebo subcutaneously (SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses.
- Arm II: Patients receive APF530 SC, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.
- Arm III: Patients receive APF530 SC at a higher dose, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC (at the same higher dose) and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.
A subset of patients undergo blood collection periodically during study for analysis of plasma APF530 concentration.
Quality of life is assessed on day 5 after completion of chemotherapy course 1.
After completion of study treatment, patients are followed at approximately 30 days.
PROJECTED ACCRUAL: A total of 1,338 patients will be accrued for this study.
Study Design
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Supportive Care
Conditions
Nausea and Vomiting
Intervention
APF530, dexamethasone, palonosetron hydrochloride, placebo
Location
Anniston Oncology, PC
Anniston
Alabama
United States
36207
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00343460
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Antiemetics
Drugs used to prevent NAUSEA or VOMITING. Antiemetics act by a wide range of mechanisms. Some act on the medullary control centers (the vomiting center and the chemoreceptive trigger zone) while others affect the peripheral receptors.
Morning Sickness
Symptoms of NAUSEA and VOMITING in pregnant women that usually occur in the morning during the first 2 to 3 months of PREGNANCY. Severe persistent vomiting during pregnancy is called HYPEREMESIS GRAVIDARUM.
Postoperative Nausea And Vomiting
Emesis and queasiness occurring after anesthesia.
Prochlorperazine
A phenothiazine antipsychotic used principally in the treatment of NAUSEA; VOMITING; and VERTIGO. It is more likely than CHLORPROMAZINE to cause EXTRAPYRAMIDAL DISORDERS. (From Martindale, The Extra Pharmacopoeia, 30th ed, p612)
Dracunculiasis
Infection with nematodes of the genus Dracunculus. One or more worms may be seen at a time, with the legs and feet being the most commonly infected areas. Symptoms include pruritus, nausea, vomiting, diarrhea, or asthmatic attacks.
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