Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)
Brief Summary: The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.


Options:
A: 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
B: Inclusion Criteria:

* Patient is greater than 18 years of age.
* Patient is scheduled to receive his/her first

course of cisplatin chemotherapy for a solid tumor.

* Patient has a prognosis (life expectancy) greater than or equal to 3 months.
C: Inclusion Criteria:

* Male or female
* 18 years of age
* A female is eligible to enter and participate in this study if she is of:

  1. Non-child-bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had at least one of the following:

     * Has had a hysterectomy, or
     * Has had a bilateral oophorectomy (ovariectomy), or
     * Has had a bilateral tubal ligation, or • Is considered post-menopausal (defined as amenorrheic for ≥ 1 year) and having serum follicle stimulating hormone (FSH) and serum estradiol concentrations consistent with post-menopausal status.
  2. Childbearing potential, has a negative serum pregnancy or negative urine pregnancy test within 24 hours prior to administration of the first dose of study medication and agrees to one of the following:

     * Complete abstinence from sexual intercourse from two weeks prior to administration of the first dose of investigational product until 30 days after the final dose of study medication.
     * Use double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm) from two weeks prior to administration of the first dose of investigational product until 30 days after the final dose of study medication.
     * Vasectomized partner who has been documented to be sterile prior to the female subject's entry and is the sole sexual partner for that female.
     * NOTE: if women of childbearing potential are enrolled, they must use double-barrier contraception in addition to oral contraceptives during the active study treatment period until 6 weeks after the final dose of study medication.
* Histologically confirmed malignant solid tumor and is scheduled to receive at least 2 courses of chemotherapy with docetaxel as a single intravenous dose of 20 to 40 mg/m2 given over a duration of one hour and repeated weekly.
* Received eight or fewer previous doses of docetaxel. Subjects that have received more than eight doses of docetaxel must receive permission from the GSK medical monitor in order to be eligible for the study.
* ECOG performance status score of less than or equal to 2

NOTE: If the subject's performance status deteriorates between the screening Visit and the time of first dose of study drug to a score \> 2, the subject will be excluded from the study

* Adequate hematologic and other physiological organ function as evidenced by Absolute Neutrophil Count ≥1500/mm3. Platelets ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL Serum creatinine \< 1.5 mg/dL Total Bilirubin ≤ upper limit of the reference range Aspartate Transaminase (AST) \< 2 x upper limit of the reference range Alanine Transaminase (ALT) \< 2 x upper limit of the reference range Alkaline Phosphatase \< 2.5 x upper limit of the reference range. Calculated creatinine clearance \> 50 mL/min (measured by Cockcroft Gault Formula;)
* Written informed consent is obtained prior to any study-specific procedures or assessments.
* Able to swallow and retain oral medications.

Exclusion Criteria:

* Pregnant or lactating.
* Received radiation therapy to the abdomen or the pelvis in the 28 days prior to receiving the first dose of study medication or that are scheduled to receive radiation therapy to the abdomen or the pelvis in the six days following the first dose of study medication.
* Received a dose of docetaxel during the week prior to Day -1.
* Known central nervous system primary or metastatic malignancy, unless successfully treated with excision or radiation and has been stable for at least 3 months prior to receiving the first dose of study medication.
* Active systemic infection or any poorly controlled medical condition (other than malignancy) which, in the opinion of the investigator, may confound the results of the study or pose an unwarranted risk to the subject. Subjects with a previous, but not current, history of alcoholism may be permitted provided that, in the investigator's opinion, the subject's disease state will not confound the results of the study.
* Receiving regular treatment with high dose systemic corticosteroid therapy or steroid dose within 72 hours prior to receiving the first dose of study medication. Topical steroids and inhaled corticosteroids with a steroid dose of less than or equal to 10 mg prednisone daily (or its equivalent) are permitted if the subject has been on this dose for at least 14 days prior to dosing.
* Hypersensitivity or contraindication to ondansetron or other 5-HT3 receptor antagonist, dexamethasone, docetaxel, casopitant, or any component of the above mentioned medications.
* Received an investigational drug within the 28 days or five half-lives (whichever is longer) prior to receiving the first dose of study medication, or is scheduled to receive any investigational drug during the study.
* Use of strong inhibitors of CYP3A4 or CYP3A5 prior to the first dose of study medication
* Use of inducers of CYP3A4 or CYP3A5 (other than steroids described in Exclusion Criteria 5) within 14 days prior to the first dose of study medication
* Use of drugs with a narrow therapeutic index that interact with the P-glycoprotein pathway within 14 days prior to the first dose of study medication until 14 days after the last dose of docetaxel including digoxin.
* Use of drugs with a narrow therapeutic index that are metabolized by CYP2C8 within 14 days prior to the first dose of study medication including repaglinide and torsemide.
* Disease that will significantly affect absorption of oral medications.
* Inadequate venous access for pharmacokinetic sampling.
* Unresolved Grade 2 or worse toxicity from prior therapy.
* Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology. NOTE: Subject is eligible to enter and participate in this study if they have a history of PUD of known etiology with documentation from a gastroenterologist or other qualified physician of the etiology of the PUD and that effective treatment was provided with full eradication of ulcers and symptoms. Subjects who present with symptoms of gastroesophageal reflux disease (GERD) are eligible. However, if the investigator suspects PUD in such a subject, the subject must have a GI assessment to rule out PUD. If assessment is negative, subject may enter the study. For these subjects, appropriate steps must also have been taken to minimize the risk of reoccurrence. If PUD was non-steroidal anti-inflammatory drug (NSAID) induced, the subject should no longer be taking NSAID medication(s). If PUD was induced by H. pylori, the subject should have been appropriately treated.
* Stool positive for occult blood. Test may be repeated once if subject did not abstain from red meat for the previous three days.
* Pepsinogen level below the lower limit of laboratory reference range (LLRR).
* Troponin level above 10% of the coefficient of variation of the assay as determined by the laboratory performing the test.
* Calculated QT interval (QTc) \> 480 msecs.
* Clinically significant cardiac disease that would interfere with participation in the study as determined by the investigator.
* Known or suspected iron deficiency.
* Use of NSAIDS, including aspirin at any dose, and including COX2 inhibitors. These medications are prohibited 7 days prior to administration of study drug and for the duration of the study until 72 hours after the last dose of study drug.
D: Inclusion Criteria:

* Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1
* Karnofsky score of 60 or greater

Exclusion Criteria:

* Patient is scheduled to receive any dose of cisplatin
* Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy
* Any allergies to study drug or antiemetics
* Taking CYP3A4 substrates/prohibited medication
* Significant medical or mental conditions
* Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).

Answer: D