Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353015
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2006-07-13
Brief Title:
Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 MD Anderson
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 MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None