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Prospective Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-based Therapy

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Trial Conditions
  • Colorectal Cancer
What is the purpose of this trial?

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.

Date & Status


Who can Participate?


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

- 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

Gender: Both
Steward Physician(s)
  • Paul J Hesketh, M.D.
  • St. Elizabeth's Medical Center - Completed
Physician Researcher

Investigator Name:

  • Paul J Hesketh, M.D.

Other Information

Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Phase: N/A
Trial ID: NCT00713128
Volunteers:  Not Accepting Healthy Volunteers

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