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Sponsored by: |
University of New Mexico |
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Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00250744 |
Condition | Intervention | Phase |
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Cancer |
Drug: Aprepitant vs. Gabapentin |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Comparison of Aprepitant vs. Gabapentin in the Prevention of Delayed Nausea and Vomiting |
Enrollment: | 200 |
Study Start Date: | December 2004 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental |
Drug: Aprepitant vs. Gabapentin
Gabapentin 300mg PO QHS day -2; 300mg PO BID day -1; 300mg PO TID days 0 through +5.
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Arm B: Active Comparator |
Drug: Aprepitant vs. Gabapentin
Aprepitant 125mg PO 60 minutes prior to chemotherapy on day 0; 80 mg PO QAM on days +1 and +2.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Exclusion Criteria:
Patients with any of the following are not eligible for enrollment in the study.
Patients with serum creatinine ≥ 2 dL/mL; bilirubin ≥ 3 times ULN; or those with an ECOG performance status
Primary or secondary (from metastatic disease) brain neoplasm with:
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.
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 |
Principal Investigator: | Stanley Cheshire | University of New Mexico |
Responsible Party: | University of New Mexico CRTC ( Stanley Cheshire, PharmD ) |
Study ID Numbers: | INST 3204C |
Study First Received: | November 4, 2005 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00250744 History of Changes |
Health Authority: | United States: Institutional Review Board |
delayed nausea and vomiting Emetogenic Chemotherapy Pilot Trial |
Excitatory Amino Acids Neurotransmitter Agents Tranquilizing Agents Vomiting Signs and Symptoms, Digestive Gabapentin Psychotropic Drugs Antiemetics Central Nervous System Depressants Calcium Channel Blockers |
Cardiovascular Agents Antimanic Agents Signs and Symptoms Calcium, Dietary Nausea Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Anticonvulsants Aprepitant |
Neurotransmitter Agents Vomiting Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiemetics Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Membrane Transport Modulators Signs and Symptoms Sensory System Agents |
Therapeutic Uses Analgesics Aprepitant Excitatory Amino Acid Antagonists Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Autonomic Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |