- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00713128
Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-based Therapy
April 11, 2011 updated by: Steward St. Elizabeth's Medical Center of Boston, Inc.
Prospective Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-based Therapy
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Brighton, Massachusetts, United States, 02135
- Caritas St. Elizabeth Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with colorectal cancer receiving Irinotecan based therapy
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
frequency of delayed emesis (vomiting/retching)
Time Frame: days 2 - 5
|
days 2 - 5
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
120 hours (days 1 thru 5)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Paul J Hesketh, M.D., Steward St. Elizabeth's Medical Center of Boston, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (ACTUAL)
December 1, 2009
Study Completion (ACTUAL)
December 1, 2009
Study Registration Dates
First Submitted
July 7, 2008
First Submitted That Met QC Criteria
July 10, 2008
First Posted (ESTIMATE)
July 11, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
April 12, 2011
Last Update Submitted That Met QC Criteria
April 11, 2011
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00455
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Cancer
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States