500 Boylston Street, Boston, MA 02116 617-419-4700
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This is a study to determine how much nausea and or vomiting is caused by irinotecan-based
chemotherapy in patients with colorectal cancer. Patients with colorectal cancer scheduled
to receive their first cycle of an irinotecan-based chemotherapy regimen are eligible. Any
chemotherapy agents administered in combination with irinotecan must have low-minimal
potential to cause nausea and or vomiting. Examples of acceptable regimens would be
irinotecan in combination with infusional fluorouracil and leucovorin (FOLFRI) with or
without bevacizumab and irinotecan in combination with cetuximab. Patients who have received
prior non-irinotecan-based chemotherapy are eligible providing they experienced no vomiting
and no greater than mild nausea with their prior chemotherapy.
Ages:18 and older
Inclusion Criteria: - Patients with colorectal cancer receiving irinotecan in combination with infusional fluorouracil and leucovorin (FOLFRI) with or without bevacizumab or irinotecan in combination with cetuximab - All patients will receive the following standard antiemetic regimen prior to chemotherapy: - Dexamethasone 8 mg PO/IV - An approved dose of a 5HT3 receptor antagonist. Ondansetron 8mg IV or 24mg PO Dolasetron 100mg IV/PO Granisetron 1 mg IV or 2mg PO Use of palonosetron will be excluded on this trial No routine prophylaxis for delayed emesis will be given. Patients will be instructed in the use of rescue antiemetics if needed. - Minimum age of 18 years. - Premenopausal patients must demonstrate a negative serum or urine pregnancy test prior to receiving chemotherapy. - ECOG performance status of 0-2 (Appendix A) - Execution of written informed consent Exclusion Criteria: - Patients with history of moderate-severe nausea or any vomiting with prior chemotherapy including irinotecan based chemotherapy. - Concomitant use of any drug with potential antiemetic efficacy (Appendix B) 24 hours before chemotherapy and during the 120 hour study period. Chronic use (more than 2 weeks) of benzodiazepines is allowed. - Vomiting, retching or nausea (NCI > 1) in the 24 hours preceding chemotherapy - Palliative surgery < 2 weeks from study entry - Concurrent radiotherapy
Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Trial ID: NCT00713128
Not Accepting Healthy Volunteers