Status:
COMPLETED
Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-based Therapy
Lead Sponsor:
Steward St. Elizabeth's Medical Center of Boston, Inc.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 f...
Detailed Description
Irinotecan is a camptothecin analog which exerts its cytotoxic effects by forming a covalent complex with topoisomerase I and DNA, resulting in inhibition of DNA re-ligation, accumulation of DNA doubl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00713128
Start Date
April 1 2008
End Date
December 1 2009
Last Update
April 12 2011
Active Locations (1)
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1
Caritas St. Elizabeth Medical Center
Brighton, Massachusetts, United States, 02135