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Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-Based Therapy
This study is currently recruiting participants.
Verified by Caritas St. Elizabeth's Medical Center of Boston, July 2008
Sponsored by: Caritas St. Elizabeth's Medical Center of Boston
Information provided by: Caritas St. Elizabeth's Medical Center of Boston
ClinicalTrials.gov Identifier: NCT00713128
  Purpose

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.


Condition
Colorectal Cancer

MedlinePlus related topics: Cancer Colorectal Cancer Nausea and Vomiting
Drug Information available for: Irinotecan Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Prospective Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-Based Therapy

Further study details as provided by Caritas St. Elizabeth's Medical Center of Boston:

Primary Outcome Measures:
  • frequency of delayed emesis (vomiting/retching) [ Time Frame: days 2 - 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 120 hours (days 1 thru 5) ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with colorectal cancer receiving Irinotecan based therapy

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713128

Contacts
Contact: Janet LaPointe, RN,OCN 617-789-3360 ext 3360 Janet.LaPointe@caritaschristi.org
Contact: Ann M Hesketh, RN, BSN 617-789-2319 ext 2319 Ann.Hesketh@caritaschristi.org

Locations
United States, Massachusetts
Caritas St. Elizabeth Medical Center Recruiting
Brighton, Massachusetts, United States, 02135
Principal Investigator: Paul J Hesketh, M.D.            
Sponsors and Collaborators
Caritas St. Elizabeth's Medical Center of Boston
Investigators
Principal Investigator: Paul J Hesketh, M.D. Caritas St. Elizabeth Medical Center
  More Information

Responsible Party: Caritas St. Elizabeth's Medical Center of Boston ( Paul J. Hesketh, M.D. Chief Division of Hematology/Oncology )
Study ID Numbers: 00455
Study First Received: July 7, 2008
Last Updated: July 10, 2008
ClinicalTrials.gov Identifier: NCT00713128  
Health Authority: United States: Institutional Review Board

Keywords provided by Caritas St. Elizabeth's Medical Center of Boston:
nausea vomiting colorectal cancer

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Vomiting
Gastrointestinal Diseases
Irinotecan
Colonic Diseases
Gastrointestinal Neoplasms
Nausea
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009