Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy

Stopped early · Not applicable · Has a placebo group

Conditions studied: Malignant Digestive System Neoplasm, Nausea and Vomiting

In brief

This randomized pilot clinical trial dolasetron mesylate and dexamethasone with or without aprepitant in preventing nausea and vomiting in patients undergoing oxaliplatin-containing chemotherapy for gastrointestinal malignancy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether giving aprepitant together with dolasetron mesylate and dexamethasone is more effective than dolasetron mesylate and dexamethasone alone in preventing nausea and vomiting.

Key facts

Study ID

NCT02550119

Run by

University of Southern California

People needed

19

Starts

2006-04-19

Expected to finish

2010-04-01

Last updated by the study team

2017-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have a diagnosis of GI malignancy and who are scheduled to receive their initial treatment with an oxaliplatin-containing regimen in combination with 5-fluorouracil; these include combinations such as fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX), FOLFOX + bevacizumab, FOLFOX + cetuximab
• 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

You may not qualify if…

• Allergy or intolerance to dolasetron and dexamethasone
• 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

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.