Radiation Therapy, Irinotecan, and Cetuximab in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Rectal Cancer
Recruitment status was: Recruiting
|First Submitted Date ICMJE||October 25, 2006|
|First Posted Date ICMJE||October 26, 2006|
|Last Update Posted Date||May 25, 2011|
|Start Date ICMJE||August 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00392470 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Radiation Therapy, Irinotecan, and Cetuximab in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Rectal Cancer|
|Official Title ICMJE||Neoadjuvant Conformal Radiotherapy and Concomitant CPT-11 and EGFR Inhibition With Cetuximab in Patients With Rectal Cancer Phase I Study|
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with irinotecan and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with cetuximab and radiation therapy in treating patients who are undergoing surgery for stage III or stage IV rectal cancer.
OUTLINE: This is a dose-escalation study of irinotecan hydrochloride.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43 followed by irinotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, and 29. Patients also undergo conformal radiotherapy or intensity-modulated radiotherapy on days 1-5 for 5 weeks. Patients undergo radical surgery 3-4 weeks after completion of neoadjuvant therapy.
Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Colorectal Cancer|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||20|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years to 74 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Switzerland|
|Removed Location Countries|
|NCT Number ICMJE||NCT00392470|
|Other Study ID Numbers ICMJE||CDR0000512816
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Centre Hospitalier Universitaire Vaudois|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||April 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP