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A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract

Phase 2
Not Enrolling
Gastrointestinal Cancer, Carcinoma, Neuroendocrine

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Trial Information

A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract

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

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.

Inclusion Criteria:

1. Histologic diagnosis of high grade (poorly differentiated, small cell)
gastrointestinal neuroendocrine carcinoma.

2. High grade neuroendocrine carcinoma of unknown primary site (if a pulmonary primary
has been excluded).

3. Metastatic or unresectable disease.

4. Measurable disease.

5. Informed consent.

6. Zubrod performance status of 0 or 1.

7. Adequate bone marrow function (defined as absolute neutrophil count [ANC] >= 1500,
platelet count [PLT] >= 100,000 and a hemoglobin [Hgb] >= 10).

8. Adequate hepatic function with a bilirubin of <= 2.0 mg/dl, and aspartate
aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) <= 2.5
times the upper limits of normal, unless caused by liver metastasis. If caused by
metastasis, then should be SGPT and SGOT <= 5 times the upper limits of normal.

9. Adequate renal function defined as serum creatinine <= 1.5 mg/dl.

10. Fertile patients and their partners must practice appropriate contraceptive methods
while on study.

11. Recovered from recent surgery. One week must have elapsed from the time of a minor
surgery and 3 weeks from major surgery.

Exclusion Criteria:

1. Patients with prior systemic chemotherapy are ineligible.

2. Other concurrent chemotherapy, immunotherapy, or radiotherapy.

3. Patients with brain metastases are not eligible. Patients with a history of seizures
are ineligible. Patients receiving phenytoin, phenobarbital, or other antiepileptic
prophylaxis are ineligible.

4. Patients with New York Heart Association (NYHA) Class III or IV heart disease are not
eligible as well as those patients with history of angina, myocardial infarction, or
congestive heart failure within six months.

5. Pregnant or lactating women. All women of child bearing potential must have a
negative pregnancy test prior to entry into the study. All patients of child bearing
potential must be advised of the importance of avoiding pregnancy and using
appropriate methods of contraception while participating in this investigational

6. Patients with serious intercurrent infections, or nonmalignant medical illnesses that
are uncontrolled or whose control may be jeopardized by the complications of this
therapy, are ineligible.

7. Patients with psychiatric disorders rendering them incapable of complying with the
requirements of the protocol are ineligible.

8. Patients with serum calcium > 12 mg/dl or symptomatic hypercalcemia under treatment
are ineligible.

9. Patients with osseous metastasis as only site of disease.

10. Patients with any concurrent active malignancy other than non-melanoma skin cancers
or carcinoma-in-situ of the cervix. Patients with previous malignancies but without
evidence of disease for > 5 years will be allowed to enter the trial.

11. Patients with known Gilbert's syndrome are ineligible.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participant Response Rate of Irinotecan and Cisplatin

Outcome Description:

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.

Outcome Time Frame:

Every 3 weeks

Safety Issue:


Principal Investigator

James C. Yao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2003

Completion Date:

July 2009

Related Keywords:

  • Gastrointestinal Cancer
  • Carcinoma, Neuroendocrine
  • Gastrointestinal cancer
  • high grade gastrointestinal neuroendocrine carcinoma
  • High grade neuroendocrine carcinoma of unknown primary site
  • Cisplatin
  • Platinol-AQ
  • Platinol
  • CDDP
  • CPT-11
  • Irinotecan
  • Carcinoma
  • Carcinoma, Neuroendocrine
  • Gastrointestinal Neoplasms



U.T. M.D. Anderson Cancer Center Houston, Texas  77030