Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00250744
First received: November 4, 2005
Last updated: September 23, 2011
Last verified: December 2009
  Purpose
  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.

Condition Intervention Phase
Cancer
Drug: Aprepitant vs. Gabapentin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Aprepitant vs. Gabapentin in the Prevention of Delayed Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

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
Experimental: Arm A Drug: Aprepitant vs. Gabapentin
Gabapentin 300mg PO QHS day -2; 300mg PO BID day -1; 300mg PO TID days 0 through +5.
Active Comparator: Arm B Drug: Aprepitant vs. Gabapentin
Aprepitant 125mg PO 60 minutes prior to chemotherapy on day 0; 80 mg PO QAM on days +1 and +2.

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 procedures.

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 randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250744

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Stanley Cheshire University of New Mexico
  More Information

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00250744     History of Changes
Other Study ID Numbers: INST 3204C
Study First Received: November 4, 2005
Last Updated: September 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
delayed nausea and vomiting
Emetogenic Chemotherapy
Pilot Trial

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive
Aprepitant
Fosaprepitant
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antiemetics
Antimanic Agents
Antiparkinson Agents
Autonomic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
Gastrointestinal Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014