Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation
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Purpose
The purpose of this study is to determine the efficacy of aprepitant in preventing acute and delayed chemotherapy induced nausea and vomiting when administered in combination with intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous transplant setting.
| Condition | Intervention | Phase |
|---|---|---|
|
Nausea Vomiting |
Drug: Ondansetron Drug: Dexamethasone Drug: Aprepitant |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Study Evaluating the Efficacy and Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combination With Ondansetron and Dexamethasone in Patients Undergoing Autologous Peripheral Blood Stem Cell Transplantation |
- To determine the efficacy of aprepitant in preventing acute & delayed chemotherapy induced nausea & vomiting when administered in combination with intravenous or oral ondansetron & intravenous or oral dexamethasone in the autologous transplant setting. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
- To measure the the severity, frequency, and duration of chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to a control group, not receiving aprepitant. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
- To measure the need for breakthrough antiemetics in patients receiving aprepitant and compare these results to the control group [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
- To assess the incidence of complications associated with chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to the control group. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
- To assess the safety of aprepitant in combination with ondansetron and dexamethasone in the autologous transplant setting. [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
| Enrollment: | 48 |
| Study Start Date: | October 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control (No aprepitant)
Regimen #1 (BEAM; NHL and HL) Carmustine 300 mg/m2 IV on day -7 (premedicate with ondansetron 32 mg IV and dexamethasone 20 mg IV) Etoposide 100 mg/m2 IV Q 12 hours x 8 doses on days -6 to -3 (premedicate first daily dose ondansetron 32 mg IV and dexamethasone 20 mg IV) Cytarabine 100 mg/m2 IV Q 12 hours x 8 doses on days -6 and -3 (no additional premedication) Melphalan 140 mg/m2 IV on day -2 (premedicate with ondansetron 32 mg IV and dexamethasone 20 mg IV) Regimen #2 (MM and Amyloidosis) Melphalan 100 mg/m2 IV on days -3 and -2 (premedicate each dose with ondansetron 32 mg IV and dexamethasone 20 mg IV) |
Drug: Ondansetron
Other Name: Zofran
Drug: Dexamethasone
|
|
Experimental: Experimental (with aprepitant)
Aprepitant 125 mg PO will be given 30 minutes prior to the first dose of chemotherapy followed by Aprepitant 80 mg PO QD for the remainder of chemotherapy and continuing for a total of 2 days after completing the regimen. Regimen #1 (BEAM; NHL and HL) Carmustine 300 mg/m2 IV on day -7 (premedicate with ondansetron 32 mg IV and dexamethasone 10 mg IV) Etoposide 100 mg/m2 IV Q 12 hours x 8 doses on days -6 to -3 (premedicate first daily dose ondansetron 32 mg IV and dexamethasone 10 mg IV) Cytarabine 100 mg/m2 IV Q 12 hours x 8 doses on days -6 and -3 (no additional premedication) Melphalan 140 mg/m2 IV on day -2 (premedicate with ondansetron 32 mg IV and dexamethasone 10 mg IV) Regimen #2 (MM and Amyloidosis) Melphalan 100 mg/m2 IV on days -3 and -2 (premedicate each dose with ondansetron 32 mg IV and dexamethasone 10 mg IV) |
Drug: Ondansetron
Other Name: Zofran
Drug: Dexamethasone
Drug: Aprepitant
Other Name: Emend
|
Eligibility| 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
- Patients deemed eligible to undergo autologous bone marrow or peripheral stem cell transplant therapy per usual transplant inclusion and exclusion criteria
- Patients with Non-Hodgkins Lymphoma, Hodgkins Lymphoma or Multiple Myeloma or Amyloidosis
- Written informed consent
Exclusion Criteria:
- Nausea at baseline
- Chronic use of other antiemetic agent(s)
- Gastrointestinal obstruction or active peptic ulcer
- Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
- Allogeneic stem cell transplant recipient
- Aspartate transaminase (AST) > 3x upper limit of normal (ULN)
- Alanine transaminase (ALT) > 3x ULN
- Bilirubin > 3x ULN
- Alkaline phosphatase > 3x ULN
- Creatinine > 2
- Documented hypersensitivity to any component of study regimen
- Pregnant or lactating women
- Participating in a clinical trial which involves other investigational agent(s)
- Patients taking any of the following medications at time of study day 1: warfarin, oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and/or diltiazem.
Contacts and Locations| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: | John F DiPersio, M.D., Ph.D. | Washington University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00314743 History of Changes |
| Obsolete Identifiers: | NCT00285272 |
| Other Study ID Numbers: | 03-1192 |
| Study First Received: | April 12, 2006 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Washington University School of Medicine:
|
Patients with Non-Hodgkins Lymphoma or Multiple Myeloma |
Additional relevant MeSH terms:
|
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Dexamethasone acetate Dexamethasone Ondansetron Aprepitant Dexamethasone 21-phosphate BB 1101 Substance P Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Antipruritics |
ClinicalTrials.gov processed this record on May 23, 2013