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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713128
• Other study ID #: 00455
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: April 11, 2011
• Start date: April 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 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.

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 double strand breaks and apoptotic cell death (1). Irinotecan is FDA approved for use in the front-line and second-line treatment of colorectal cancer. It has also demonstrated activity in a variety of other non-hematologic tumors. The recently updated ASCO antiemetic guidelines characterize irinotecan as having moderate emetic risk. (2). However, the emetogenic potential of this agent has been poorly characterized and there are no published prospective trials with emesis as a primary-end point. In addition there is a complete paucity of information on the potential of irinotecan to induce emesis beyond the first day after chemotherapy, so-called delayed emesis. Best characterized following cisplatin, delayed emesis is also associated with a number of other chemotherapy agents that similar to irinotecan appear to be moderately emetogenic such as carboplatin, cyclophosphamide and doxorubicin. Antiemetic prophylaxis for delayed emesis following irinotecan is not routinely prescribed at the present time. Prospectively obtained information on the potential of irinotecan to cause delayed emesis would be helpful in guiding appropriate antiemetic practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Vomiting

Locations

Country	Name	City	State
United States	Caritas St. Elizabeth Medical Center	Brighton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Steward St. Elizabeth's Medical Center of Boston, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of delayed emesis (vomiting/retching)		days 2 - 5	No
Secondary	Freq. of mild-severe nausea D 2-6 Freq. use of antiemetics D 2-6, Pts.with complete response(no emesis/use of rescue antiemtics)D 1, Pts. with total control (no:emesis,nausea, use of rescue antiemetics)D 2-6, Overall satisfaction		120 hours (days 1 thru 5)	No