Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting

Completed · Phase 2

Conditions studied: Cancer

In brief

1. To compare the effectiveness of gabapentin (titrated to300mg TID days -2 to 5) with aprepitant (125mg on day 1 and 80mg on days 2 and 3) in the control of delayed nausea and vomiting associated with level 3, 4 or 5 emetogenic chemotherapy in patients who experienced delayed nausea and/or vomiting during their first cycle of chemotherapy. 2. To evaluate and compare the safety profile associated with each anti-emetic regimen. 3. To assess subject satisfaction with anti-emetic therapy.

Key facts

Study ID

NCT00250744

Run by

New Mexico Cancer Research Alliance

People needed

200

Starts

2004-12-01

Expected to finish

2007-09-01

Last updated by the study team

2011-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients, 18 years of age or older, who are eligible for chemotherapy may participate in the trial if the following criteria are met:
• Patients must have a diagnosis of malignant disease and be scheduled to receive single-day intravenous chemotherapy drug or combination of drugs that are considered to elicit level 3, 4 or 5 emesis (appendix A).
• Males must be surgically sterilized, or agree to practice adequate contraceptive precautions during the study.
• Females of non-childbearing potential (i.e. those who have been surgically sterilized, or who are at least one-year post menopausal) may enter the study. Females of childbearing potential must have a negative pregnancy test (urine or serum hCG) before entry into the study, and must agree to practice adequate contraceptive precautions during the study.
• Written informed consent must be obtained before initiating any protocol specified procedures.

You may not qualify if…

• Patients with any of the following are not eligible for enrollment in the study.
• Any unstable medical disorder.
• Participation in any drug trial in which the patient received an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the screening phase of this study.
• Patients with serum creatinine ≥ 2 dL/mL; bilirubin ≥ 3 times ULN; or those with an ECOG performance status ≥ 3.
• Patients with severe hepatic insufficiency as evidenced by ascites, encephalopathy, coagulopathy, or jaundice.
• Patients prescribed corticosteroids except for replacement or maintenance doses up to 10mg prednisone or equivalent. Dexamethasone is permitted as a prophylactic component of the pre- and post-chemotherapy anti-emetic regimen as defined in this protocol.
• Primary or secondary (from metastatic disease) brain neoplasm with:
• Signs or symptoms of increased intracranial pressure or
• Patients with brain metastases requiring treatment within 30 days of entry into the study.
• Signs or symptoms of cerebral edema will exclude a patient from entry into the study. Patients with symptomatically "silent" metastases may be enrolled into the study.
• Patients who are known to be hypersensitive to gabapentin, any neurokinin-1 or dopamine receptor antagonist, 5-HT3 receptor antagonists, or corticosteroids.
• Patients who are unwilling or unable to comply with the protocol.
• Patients are excluded if they are receiving radiation therapy to any abdominal field (T10-L5) within 24 hours before the dose of study medication is given or if they are scheduled to receive such radiation during the period of assessment (study days 0-2 for arm A and study days 0-6 for arm B). Radiation to other fields is acceptable (e.g. pelvic radiation, thoracic radiation).
• Patients who have had any nausea within one hour and/or emesis (vomiting and/or retching) within 24 hours before dosing of study medication.
• Patients who have taken either gabapentin or aprepitant within four weeks of randomization.

Where it is running

• University of New Mexico — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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