Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT00713128
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00713128
Study Brief:
Protocol Section:
NCT00713128