Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract
Tracking Information | |||||
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First Received Date ICMJE | July 13, 2006 | ||||
Last Updated Date | August 1, 2012 | ||||
Start Date ICMJE | March 2003 | ||||
Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Participant Response Rate of Irinotecan and Cisplatin [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ] Clinical activity defined by number of participants with Complete Response (CR) and Partial Response (PR) divided by total number of particpants using Response Evaluation Criteria in Solid Tumors (RECIST) where changes in tumor measurements confirmed by repeat assessments no less than 4 weeks after criteria for CR and PR responses first met. |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00353015 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE |
Chest x-ray will be obtained at the time of response evaluation. [ Time Frame: Every 9 weeks ] [ Designated as safety issue: No ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract | ||||
Official Title ICMJE | A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract | ||||
Brief Summary | Primary Objective: 1. Assess the clinical activity defined by response rate of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract. Secondary Objective: 1. To assess the safety profile of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract. |
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Detailed Description | Both irinotecan and carboplatin are drugs commonly used to treat cancer. Before treatment starts, patients will have blood tests (around 4 teaspoons) and urine tests. Patients will have a chest X-ray, an electrocardiogram (ECG-a test to measure the electrical activity of the heart), and a computed tomography (CT) scan. Women who are able to have children must have a negative blood pregnancy test. During the study, patients will receive irinotecan and cisplatin by vein over 4 hours, once a week for 2 weeks. This will be followed by 7 days in which no treatment will be given. This 3 week period is called a cycle. Cycles will be repeated unless the tumor continues to grow. During treatment, patients will have follow-up visits every 3 weeks to check for any side effects and the status of the disease. The follow-up visits may be with either your local doctor or with the study doctor. However, visits with the study doctor should be scheduled at least every 9 weeks. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study. This is an investigational study. Both irinotecan and cisplatin are FDA approved and commercially available. Around 36 patients will participate in the study. All patients will be enrolled at M.D. Anderson. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | Experimental: Irinotecan plus Cisplatin
Irinotecan 65 mg/m2 and Cisplatin 25 mg/m2 intravenous (IV) days 1, 8 of a 21-day cycle
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 21 | ||||
Completion Date | July 2009 | ||||
Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | |||||
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 | NCT00353015 | ||||
Other Study ID Numbers ICMJE | ID02-523 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | Pharmacia | ||||
Investigators ICMJE |
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Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | August 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |