Status:
COMPLETED
Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting
Lead Sponsor:
New Mexico Cancer Research Alliance
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 wit...
Detailed Description
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. Pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00250744
Start Date
December 1 2004
End Date
September 1 2007
Last Update
September 27 2011
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131