Clinical Trial: Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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.


Detailed Summary:

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.


Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Participant Response Rate of Irinotecan and Cisplatin [ Time Frame: Every 3 weeks ]

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.


Original Primary Outcome:

  • Prior to each dose of chemotherapy, CBC. If platelet count is < 50,000/mm3, frequent platelet counts until the platelet count is >50,000/mm3 or clearly rising
  • Prior to each course of chemotherapy (every 3 weeks), CBC, serum chemistries, LDH, SGPT, electrolytes
  • At time of response evaluation, In addition to above. CEA, chromogranin A
  • Following the completion of 3 course = 9 weeks of treatment, assess all measurable or evaluable lesions
  • Chest x-ray will be obtained at the time of response evaluation


Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: July 13, 2006
Date Started: March 2003
Date Completion:
Last Updated: August 1, 2012
Last Verified: August 2012