Weekly Oxaliplatin and Irinotecan in Recurrent or Metastatic Esophageal Carcinoma
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | November 17, 2005 | ||||
Last Updated Date | August 15, 2011 | ||||
Start Date ICMJE | June 2005 | ||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
To assess the overall response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
To assess the overall response rate | ||||
Change History | Complete list of historical versions of study NCT00256269 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
To assess the frequency and severity of toxicities [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
To assess the frequency and severity of toxicities | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Weekly Oxaliplatin and Irinotecan in Recurrent or Metastatic Esophageal Carcinoma | ||||
Official Title ICMJE | A Phase II Study of Weekly Oxaliplatin and Irinotecan in the Treatment of Recurrent or Metastatic Esophageal Carcinoma | ||||
Brief Summary | The combination of cisplatin and irinotecan has significant anti-tumor activity in esophageal cancer. Oxaliplatin has been shown to have activity in combination with 5 FU and radiation in treatment of locally advanced esophageal cancer. Oxaliplatin also has better side effects profile than cisplatin and may be able to overcome tumors that have developed cisplatin resistance. The standard treatment of locally advanced esophageal cancer has been cisplatin, 5FU and radiation followed by possible esophagectomy. However, a large portion of these patients will relapse and the tumor may develop resistance to cisplatin and/or the cumulative toxicity from previous treatment forbids the use of cisplatin again. Weekly combination of oxaliplatin and irinotecan has been shown to be active and well tolerated in elderly population with refractory colorectal cancer. Therefore, we propose this phase II trial of a weekly oxaliplatin and irinotecan to test the effectiveness and the tolerability of this regimen in metastatic and/or recurrent esophageal cancer. |
||||
Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 4 | ||||
Completion Date | April 2011 | ||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00256269 | ||||
Other Study ID Numbers ICMJE | UCI 04-09, 2004-3849 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Sai-Hong Ignatius Ou, MD, University of California, Irvine | ||||
Study Sponsor ICMJE | University of California, Irvine | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | University of California, Irvine | ||||
Verification Date | August 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |