Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Pivotal Phase 3 Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi For The Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following The Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens
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 chemotherapy for cancer.


Options:
A: Inclusion Criteria:

* Age: ≥20 years old
* Sex: Not specified
* Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen including oxaliplatin at ≥85 mg/m2 (naive patient), or those who had already started chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier course (non-naive patient).
* Stage: not specified (neoadjuvant/adjuvant chemotherapy, advanced or recurrent type are allowed)
* Combination of molecular targeted therapy: allowable
* Written informed consent for participation in the study.

Exclusion Criteria:

* Severe liver or kidney disease
* Nausea/vomiting within 24 hr prior to chemotherapy.
* Treatment with antiemetics within 24 hr prior to chemotherapy.
* Presence of factors causing nausea/vomiting other than chemotherapy (e.g. brain tumor, gastrointestinal obstruction, active peptic ulcer disease, brain metastasis)
* Presence of a disease precluding 3-day administration of dexamethasone (e.g. uncontrollable diabetes)
* Pregnant or lactating women, women who plan to become pregnant.
* Current treatment with pimozide.
* Any patient judged to be inappropriate for the study by the investigator.
B: 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
C: DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Planning to receive cyclophosphamide 600 mg/m²-1,000 mg/m² IV infusion

  * No cyclophosphamide dose change between courses 1 and 2

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 2 months
* ANC ≥ 1,500/μL
* Platelet count ≥ 100 x 10\^9/L
* Hemoglobin ≥ 9.0 g/dL
* Serum creatinine ≤ 1.5 mg/dL
* AST/ALT ≤ 2 times upper limit of normal
* Not pregnant or nursing
* No contraindication to aprepitant

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent medications that are CYP3A4 substrates, inhibitors, and/or inducers, with the exception of the dexamethasone contained as part of the standard antiemetic regimen
D: Inclusion Criteria:

* Histologic, serologic or clinical evidence of germ cell tumor.
* Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy on permitted regimens
* Prior chemotherapy is allowed. Patients will be stratified based on previous treatment.
* Male patients 15 years of age or older at time of registration.
* Patient will provide written informed consent and authorization to release personal health information.

Exclusion Criteria:

* No known history of anticipatory nausea or vomiting.
* No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.
* No known central nervous system (CNS) metastasis.
* No known hypersensitivity to any component of study regimen.
* No concurrent participation in a clinical trial which involves another investigational agent.
* No use of warfarin while on study.
* No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.
* No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics (Erythromycin, Clarithromycin, Azithromycin), azole antifungal agents (Ketoconazole, Itraconazole, Voriconazole, Fluconazole), Amifostine, Nelfinavir and Ritonavir.

Answer: B