|Exclusion Criteria:||1) Inability or unwillingness to understand or cooperate with the study procedures as determined by the Investigator.|
2) Women who are pregnant, nursing or planning to become pregnant, women of childbearing potential who are not using an effective method of pregnancy prevention (including implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomized partner or sexual abstinence), ....continued on # 3
3) continued from # 2 .......or women who have had a positive serum pregnancy test at screening or within 7 days prior to receiving chemo on Day 1. Non-childbearing potential includes women who are post-menopausal (12 months of amenorrhea with no other demonstrable cause, in the appropriate age group) or documented surgical sterilization, or hysterectomy at least 3 months before the study start.
4) Previous use of palonosetron in association with a LEC regimen.
5) Received more than one antiemetic agent for prevention of CINV during their last cycle of LEC (other thatn dexamethasone or prednisone as outlined in number 8 below). the use of an antiemetic in addition to a corticosteroid during the last cycle of LEC is allowed if the corticosteroid is intended for the prophylactic treatmetn of taxane-related hypersensitivity or pemetrexed-related skin reactions as long as the corticosteroid regimen remains unchanged during the trial.
6) Suspected or confirmed ongoing vomiting for any organic etiology (e.g., food poisoning, gastroenteritis, etc.)
7) Received any drug with potential anti-emetic effect within 24 hours prior to the start of qualifying LEC agent.
8) Scheduled to receive an antiemetic (with the exception of administration of the palonosetron) at any time during the trial, listed below: (1) 5-HT3 receptor antagonists: (2) NK1 receptor antagonists; (3) Dopamine receptor antagonists (metoclopramide); (4) Phenothiazine anti-emetics) prochlorperazine, promethazine, thiethylperazine and perhyenazine); .........continued on # 9
9) .......continued from # 8 ; (5) Diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide. Diphenhydramine will be allowed if given for prophylactic treatment of hyppersensitivity reactions associated with the administration of taxanes (e.g. Paclitaxel, docetaxel) and ixabepilone; (6) All benzodiaxepines except Triazolam or Zolpidem used once at night time due to sleep disturbances; (7) Atypical antipsychotic agents with compazine-like activity (e.g., olazapine, risperidone); (8) Butyrophenones (Haloperidol, droperidol); ...........continued on #10
10) ......continued from # 9. (9) Cannabinoides (tetrahydrocannabinol or nabilone); (10) Any systemic corticosteroid (hydrocortisone, metylprednisolone, prednisone), with the exception of topicalor inhaled preparations. Dexamethasone will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes (e.g., paclitaxel, docetaxel) or prevention of rash associated with pemetrexed. Prednisone will be allowed if given for as part of standard regimen with mitoxatrone or docetaxel for prostate cancer...........continued on # 11
11) continued from # 10 ..... (11) Any non-prescription medication, nutritional supplements, vitamins or herbal-type products known to either possibly cause nausea or vomiting, or used to treat nausea or vomiting.
12) Having received any investigational drugs or devices within 30 days before study entry.
13) Any vomiting, retching, or National Cancer Institute Common Terminology Criteria for Adverse Events, v.3 (NCI CTCAE) Grade 2 to 4 nausea in the 24 hours preceding chemotherapy.
14) History of alcohol or drug abuse.
15) Scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified int the protocol.
16) Any known hypersensitivity/contraindication to 5-HT3 antagonists or study drug excipients.
17) Schehuled to receive or have received radiotherapy within 1 week prior to or during the study.
18) Any condition that, in the judgement of the PI, would make a subject ineligible for participation in the study.