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

This study has been completed.
Sponsor:
Information provided by:
Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT00713128
First received: July 7, 2008
Last updated: April 11, 2011
Last verified: February 2009
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-based Therapy

Resource links provided by NLM:


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

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 ]

Estimated Enrollment: 50
Study Start Date: April 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (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

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

No publications provided

Responsible Party: Paul J. Hesketh, M.D. Chief Division of Hematology/Oncology, Caritas St. Elizabeth's Medical Center of Boston
ClinicalTrials.gov Identifier: NCT00713128     History of Changes
Other Study ID Numbers: 00455
Study First Received: July 7, 2008
Last Updated: April 11, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Nausea
Vomiting
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014