Trials / Completed
CompletedNCT00075439
Gefitinib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
A Phase II Trial of ZD1839 (Iressa®) in Metastatic Neuroendocrine Tumors
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well gefitinib works in treating patients with progressive metastatic neuroendocrine tumors. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Detailed description
PRIMARY OBJECTIVES: I. To determine the 6 month progression free survival rate in patients with progressive, advanced neuroendocrine tumors treated with ZD1839. SECONDARY OBJECTIVES: I. Objective tumor response rate. II. Progression free survival and time to progression. III. Improvement in circulating hormone levels. IV. Overall survival V. We will explore the molecular characterization of these tumors in attempt to understand the role of EGFR expression and its inhibition with ZD1839 in neuroendocrine tumors. The measurements will be performed on pretreatment and post-treatment tumor biopsies when possible: EGFR expression and gene amplification (IHC for EGFR and phosphorylated EGFR, ISH for gene amplification); Activation of the Ras/Raf/MAPK pathway (IHC for phosphorylated MAPK); Cell proliferation (Ki-67 staining); Apoptosis (TUNEL assay). OUTLINE: This is a multicenter study. Patients are stratified according to disease type (carcinoid vs islet cell and other neuroendocrine tumors). Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.
Conditions
- Gastrinoma
- Glucagonoma
- Insulinoma
- Metastatic Gastrointestinal Carcinoid Tumor
- Pancreatic Polypeptide Tumor
- Recurrent Gastrointestinal Carcinoid Tumor
- Recurrent Islet Cell Carcinoma
- Somatostatinoma
- WDHA Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | gefitinib | Given orally |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2003-12-01
- Primary completion
- 2007-05-01
- First posted
- 2004-01-12
- Last updated
- 2013-06-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00075439. Inclusion in this directory is not an endorsement.