Home
Search
Study Topics
Glossary
|
|
|
|
|
|
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 |
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: | Case-Only, Prospective |
Official Title: | Prospective Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-Based Therapy |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with colorectal cancer receiving Irinotecan based therapy
Inclusion Criteria:
Exclusion Criteria:
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 |
United States, Massachusetts | |
Caritas St. Elizabeth Medical Center | Recruiting |
Brighton, Massachusetts, United States, 02135 | |
Principal Investigator: Paul J Hesketh, M.D. |
Principal Investigator: | Paul J Hesketh, M.D. | Caritas St. Elizabeth Medical Center |
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 |
nausea vomiting colorectal cancer |
Digestive System Diseases Digestive System Neoplasms Vomiting Gastrointestinal Diseases Irinotecan Colonic Diseases |
Gastrointestinal Neoplasms Nausea Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |