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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00353015
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : August 2, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Carcinoma, Neuroendocrine Drug: Cisplatin Drug: Irinotecan Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract
Study Start Date : March 2003
Actual Primary Completion Date : December 2007
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: Irinotecan plus Cisplatin
Irinotecan 65 mg/m2 and Cisplatin 25 mg/m2 intravenous (IV) days 1, 8 of a 21-day cycle
Drug: Cisplatin
Cisplatin 25 mg/m2 IV days 1, 8 of a 21-day cycle
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP

Drug: Irinotecan
Irinotecan 65 mg/m2 IV days 1, 8 of a 21-day cycle
Other Name: CPT-11

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 trial.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00353015

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United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: James C. Yao, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00353015     History of Changes
Other Study ID Numbers: ID02-523
First Posted: July 17, 2006    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by M.D. Anderson Cancer Center:
Gastrointestinal cancer
high grade gastrointestinal neuroendocrine carcinoma
High grade neuroendocrine carcinoma of unknown primary site

Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action