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

NCT00250744 | Completed Phase 2 DMC

• 1 other identifier: INST 3204C
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate and compare the safety profile associated with each anti-emetic regimen.
3. 3.To assess subject satisfaction with anti-emetic therapy.

Conditions

Cancer

Keywords

delayed nausea and vomiting; Emetogenic Chemotherapy; Pilot Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Aprepitant vs. Gabapentin

Arm B

ACTIVE COMPARATOR

Drug: Aprepitant vs. Gabapentin

Interventions

Aprepitant vs. Gabapentin DRUG

Gabapentin 300mg PO QHS day -2; 300mg PO BID day -1; 300mg PO TID days 0 through +5.

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Neoplasms; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stanley Cheshire

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 8, 2005
• Study Start: December 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: September 27, 2011

Record last verified: 2009-12

Locations

US (1)