Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT00394966
Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 years of age or older.
* Subject has never been treated with cisplatin and is to receive first course of cisplatin-based chemotherapy (\>=70 mg/m\^2).
* Subject has a Karnofsky performance score of \>=60.
* Subject has a predicted life expectancy of \>=3 months.
* Subject has adequate bone marrow, kidney, and liver function as evidenced by:
* Absolute neutrophil count \>=1,500/mm3 and white blood cell count \>=3,000/mm3.
* Platelet count \>=100,000/mm3.
* Aspartate aminotransferase (AST) \<=2.5 x upper limit of normal (ULN) range.
* Alanine aminotransferase (ALT) \<=2.5 x ULN.
* Bilirubin \<=1.5 x ULN, except for subjects with Gilbert's syndrome.
* Creatinine \<=1.5 x ULN.
* Subject is able to read, understand, and complete the questionnaires.
Exclusion Criteria:
* Any current treatment or medical history (eg, subject is mentally incapacitated or has a psychiatric disorder) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject.
* Subject has contraindication to the administration of cisplatin, ondansetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, hearing impairment, or systemic fungal infection.
* Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6.
* Subject is scheduled to receive any radiation therapy to the abdomen or pelvis within 5 days prior to and/or during Days 1 through 5 following cisplatin infusion.
* Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
* Subject has ongoing vomiting caused by any etiology or has a history of anticipatory nausea and vomiting.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00394966
Study Brief:
Protocol Section:
NCT00394966