Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Pharmacia
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00353015

Purpose

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	Intervention	Phase
Gastrointestinal Cancer Carcinoma, Neuroendocrine	Drug: Cisplatin Drug: Irinotecan	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Complete blood count (CBC). If platelet count is < 50,000/mm3, frequent platelet counts until the platelet count is > 50,000/mm3 or clearly rising [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
Prior to each course of chemotherapy (every 3 weeks), CBC, serum chemistries, lactate dehydrogenase (LDH), SGPT, electrolytes [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
At time of response evaluation, in addition to above. Carcinoembryonic antigen (CEA), chromogranin A [ Time Frame: Every 9 weeks ] [ Designated as safety issue: No ]
Following the completion of 3 course = 9 weeks of treatment, assess all measurable or evaluable lesions [ Time Frame: Every 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Chest x-ray will be obtained at the time of response evaluation. [ Time Frame: Every 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	March 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Irinotecan plus Cisplatin	Drug: Cisplatin Cisplatin 25 mg/m2 IV days 1, 8 of a 21-day cycle Drug: Irinotecan Irinotecan 65 mg/m2 IV days 1, 8 of a 21-day cycle

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 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologic diagnosis of high grade (poorly differentiated, small cell) gastrointestinal neuroendocrine carcinoma.
High grade neuroendocrine carcinoma of unknown primary site (if a pulmonary primary has been excluded).
Metastatic or unresectable disease.
Measurable disease.
Informed consent.
Zubrod performance status of 0 or 1.
Adequate bone marrow function (defined as absolute neutrophil count [ANC] >= 1500, platelet count [PLT] >= 100,000 and a hemoglobin [Hgb] >= 10).
Adequate hepatic function with a bilirubin of <= 2.0 mg/dl, and SGPT and SGOT <= 2.5 x the upper limits of normal, unless caused by liver metastasis. If caused by metastasis, then SGPT and SGOT should be <= 5 x the upper limits of normal.
Adequate renal function defined as serum creatinine <= 1.5 mg/dl.
Fertile patients and their partners must practice appropriate contraceptive methods while on study.
Recovered from recent surgery. One week must have elapsed from the time of a minor surgery and 3 weeks from major surgery.

Exclusion Criteria:

Patients with prior systemic chemotherapy are ineligible.
Other concurrent chemotherapy, immunotherapy, or radiotherapy.
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.
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.
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.
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.
Patients with psychiatric disorders rendering them incapable of complying with the requirements of the protocol are ineligible.
Patients with serum calcium > 12 mg/dl or symptomatic hypercalcemia under treatment are ineligible.
Patients with osseous metastasis as only site of disease.
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.
Patients with known Gilbert's syndrome are ineligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353015

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Pharmacia

Investigators

Principal Investigator:

James C. Yao, MD

M.D. Anderson Cancer Center

More Information

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	The University of Texas M. D. Anderson Cancer Center ( James Yao, M.D./Associate Professor )
Study ID Numbers:	ID02-523
Study First Received:	July 13, 2006
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00353015
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Gastrointestinal cancer
high grade gastrointestinal neuroendocrine carcinoma
High grade neuroendocrine carcinoma of unknown primary site
Cisplatin
Platinol-AQ
Platinol

CDDP
CPT-11
Irinotecan
high grade gastrointestinal neuroendocrine carcinoma
High grade neuroendocrine carcinoma of unknown primary site

Study placed in the following topic categories:

Digestive System Neoplasms
Carcinoma, Neuroendocrine
Gastrointestinal Diseases
Irinotecan
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors

Digestive System Diseases
Cisplatin
Neoplasms, Germ Cell and Embryonal
Gastrointestinal Neoplasms
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009