Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy
NCT ID: NCT02550119
Last Updated: 2017-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2006-04-19
2010-04-01
Brief Summary
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Detailed Description
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I. To estimate the incidence and severity of acute and delayed nausea and vomiting associated with oxaliplatin-containing regimens in patients with gastrointestinal (GI) malignancy.
II. To estimate the percent of patients who have experienced nausea and vomiting with their first or second cycle of oxaliplatin-containing regimen, and would consent to randomization to standard antiemetic therapy with or without aprepitant.
III. To obtain preliminary data on the safety and efficacy of aprepitant, in combination with dolasetron (dolasetron mesylate) and dexamethasone, in patients receiving oxaliplatin-containing regimen.
IV. To report on medication compliance with antiemetic medications (dexamethasone and aprepitant or placebo) scheduled to be taken at home on days 2 and 3 for all randomized patients (day 1 = day of treatment).
OUTLINE: Patients receive standard antiemetics comprising dolasetron mesylate orally (PO) or intravenously (IV) and dexamethasone PO or IV during course 1 of oxaliplatin-containing chemotherapy. Patients experiencing any grade 1-4 nausea and vomiting\* are randomized to 1 of 2 treatment arms.
ARM I: Patients receive dolasetron mesylate PO or IV, dexamethasone PO or IV, and aprepitant PO 1 day before chemotherapy and dexamethasone PO and aprepitant PO on days 2 and 3 after chemotherapy begins during course 2-3.
ARM II: Patients receive dolasetron mesylate and dexamethasone as in Arm I and placebo PO 1 day before chemotherapy and dexamethasone PO and placebo PO on days 2 and 3 after chemotherapy begins during courses 2-3.
In both arms, treatment continues in the absence of unacceptable toxicity.
NOTE: \* Patients not developing nausea and vomiting until the second course of treatment are also randomized during courses 3 and 4 of chemotherapy.
After completion of study treatment, patients are followed up periodically.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (aprepitant, dolasetron mesylate, dexamethasone)
Patients receive dolasetron mesylate PO or IV, dexamethasone PO or IV, and aprepitant PO 1 day before chemotherapy and dexamethasone PO and aprepitant PO on days 2 and 3 after chemotherapy begins during course 2-3.
Aprepitant
Given PO
Dexamethasone
Given PO or IV
Dolasetron Mesylate
Given PO or IV
Arm II (placebo, dolasetron mesylate, dexamethasone)
Patients receive dolasetron mesylate and dexamethasone as in Arm I and placebo PO 1 day before chemotherapy and dexamethasone PO and placebo PO on days 2 and 3 after chemotherapy begins during courses 2-3.
Dexamethasone
Given PO or IV
Dolasetron Mesylate
Given PO or IV
Placebo
Given PO
Interventions
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Aprepitant
Given PO
Dexamethasone
Given PO or IV
Dolasetron Mesylate
Given PO or IV
Placebo
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Standard antiemetic therapy with initial treatment must include the dolasetron and dexamethasone; the minimum adequate doses include either:
* Dolasetron (Anzemet) 100mg PO/IV or 1.8mg/kg IV AND
* Dexamethasone (Decadron) 10mg PO/IV
* Patient must agree, as part of the informed consent, to keep a journal of the episodes of nausea, vomiting, retching, and amount of rescue medications used on days 1 to 5 (day 1 = day of treatment)
* Signed informed consent
Exclusion Criteria
* Use of another antiemetic agent (5HT3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours of day 1 of the study
* An episode of vomiting or retching within 24 hours before the start of the initial treatment with oxaliplatin-containing regimen
* Severe concurrent illness other than neoplasia
* Gastrointestinal obstruction or an active peptic ulcer
* Radiation therapy to the abdomen or pelvis within 1 week before or after day 1 of the study
* Absolute neutrophil count of less than 1.5 x 10\^9/L (unless physician approves to proceed with chemotherapy) or
* Platelets less than 100 x 109/L (unless physician approves to proceed with chemotherapy)
* Total bilirubin \> 2 x upper limits of normal
* Patients who are pregnant or breast feeding
* Patients who are non-English speaking
* Patients with cancer-induced nausea and vomiting grade 1 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Betty Chan
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2012-01740
Identifier Type: REGISTRY
Identifier Source: secondary_id
3C-06-1
Identifier Type: OTHER
Identifier Source: secondary_id
3C-06-1
Identifier Type: -
Identifier Source: org_study_id
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