Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Pharmacia
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00353015
First received: July 13, 2006
Last updated: August 1, 2012
Last verified: August 2012

July 13, 2006
August 1, 2012
March 2003
December 2007   (final data collection date for primary outcome measure)
Participant Response Rate of Irinotecan and Cisplatin [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
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.
  • 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
Complete list of historical versions of study NCT00353015 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract
A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastrointestinal Cancer
  • Carcinoma, Neuroendocrine
  • 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
Experimental: Irinotecan plus Cisplatin
Irinotecan 65 mg/m2 and Cisplatin 25 mg/m2 intravenous (IV) days 1, 8 of a 21-day cycle
Interventions:
  • Drug: Cisplatin
  • Drug: Irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2009
December 2007   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00353015
ID02-523
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Pharmacia
Principal Investigator: James C. Yao, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP