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Comparison of Aprepitant vs. Gabapentin in the Prevention of Delayed Nausea and Vomiting

Phase 2
18 Years
Not Enrolling

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Trial Information

Comparison of Aprepitant vs. Gabapentin in the Prevention of Delayed Nausea and Vomiting

The purpose of study is to compare the effectiveness of aprepitant and gabapentin in
treating "delayed" (days later) nausea and/or vomiting for patients receiving chemotherapy
treatment for cancer. Patients on the study will receive aprepitant or gabapentin in
addition to the standard medications used to prevent nausea and vomiting. Aprepitant is
approved by the FDA for nausea and vomiting. Gabapentin is approved by the FDA for the
treatment of seizures but it may be effective in controlling nausea and vomiting due to
chemotherapy. Subjects receiving aprepitant will be receiving a proven treatment for delayed
nausea and vomiting, while subjects receiving gabapentin will be receiving a drug that has
only shown limited effectiveness.

Patients are eligible for participation in this study because they are going to receive
chemotherapy that may cause nausea or vomiting. If patients have delayed nausea or vomiting
after the first cycle of treatment, they will be offered a chance to receive additional
treatments with their second cycle of chemotherapy. The University of New Mexico Health
Sciences Center is sponsoring the study.

The first 40 patients enrolled in the study will participate in the pilot phase of the
study. A pilot study is a smaller version of a full study to determine how effective the
treatments are. All 40 patients in the pilot phase of the study will come from UNM. If the
pilot phase is found to be successful, then the study will continue and approximately 200
patients will eventually be enrolled. The full study will be conducted at the University of
New Mexico Cancer Research and Treatment Center (UNM CRTC), the New Mexico VA Healthcare
System, and at members of the New Mexico Cancer Care Alliance.

Inclusion Criteria:

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:

1. 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).

2. Males must be surgically sterilized, or agree to practice adequate contraceptive
precautions during the study.

3. 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.

4. Written informed consent must be obtained before initiating any protocol specified

Exclusion Criteria:

Patients with any of the following are not eligible for enrollment in the study.

1. Any unstable medical disorder.

2. 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.

3. Patients with serum creatinine ≥ 2 dL/mL; bilirubin ≥ 3 times ULN; or those with an
ECOG performance status ≥ 3.

4. Patients with severe hepatic insufficiency as evidenced by ascites, encephalopathy,
coagulopathy, or jaundice.

5. 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.

6. 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.

7. Patients who are known to be hypersensitive to gabapentin, any neurokinin-1 or
dopamine receptor antagonist, 5-HT3 receptor antagonists, or corticosteroids.

8. Patients who are unwilling or unable to comply with the protocol.

9. 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).

10. Patients who have had any nausea within one hour and/or emesis (vomiting and/or
retching) within 24 hours before dosing of study medication.

11. Patients who have taken either gabapentin or aprepitant within four weeks of

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To compare the effectiveness of gabapentin with aprepitant in the control of delayed nausea & vomiting associated with level 3, 4 or 5 emetogenic chemotherapy in pts who experienced delayed nausea and/or vomiting during their first cycle of chemotherapy.

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Stanley Cheshire

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:

INST 3204C



Start Date:

December 2004

Completion Date:

September 2007

Related Keywords:

  • Cancer
  • delayed nausea and vomiting
  • Emetogenic Chemotherapy
  • Pilot Trial
  • Nausea
  • Vomiting



University of New Mexico Albuquerque, New Mexico  87131