Gefitinib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

Completed · Phase 2

Conditions studied: Gastrinoma, Glucagonoma, Insulinoma, Metastatic Gastrointestinal Carcinoid Tumor, Pancreatic Polypeptide Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Islet Cell Carcinoma, Somatostatinoma, WDHA Syndrome

In brief

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.

Key facts

Study ID

NCT00075439

Run by

National Cancer Institute (NCI)

People needed

90

Starts

2003-12-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed metastatic neuroendocrine neoplasms or histologic confirmation of primary neuroendocrine tumor with clear clinical evidence of metastases
• Measurable disease
• Radiographic evidence of disease progression, following any prior systemic therapy, chemoembolization, embolization, or observation; for eligibility purposes, disease progression will be defined as follows:
• Either of the following documented by comparison of the on-study radiographic assessment with a prior assessment of the same type performed within the previous 60 calendar weeks:
• Appearance of a new lesion
• At least 20% increase in the longest diameter (LD) of any previously documented lesion or an increase in the sum of the LDs of multiple lesions in aggregate of 20%
• ≥4 weeks from the completion of major surgery, chemotherapy or other systemic therapy and hepatic artery embolization/chemoembolization to study registration
• ≥3 weeks from the completion of radiation therapy to study registration
• Recovered sufficiently from side effects of prior therapy
• Absolute neutrophil count (ANC) ≥ 1000/mm3
• PLT ≥ 75,000/ mm3
• Hgb ≥ 8.0 g/dL
• Total bilirubin ≤ 2 x upper normal limit (UNL)
• Alkaline phosphatase ≤ 3 x UNL (5 x UNL if liver metastases present)
• AST ≤ 3 x UNL (≤ 5 x UNL if liver metastases present)
• Creatinine ≤ 1.5 x UNL
• ECOG performance score (ps) ≤ 2
• Life expectancy ≥ 24 weeks
• Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent

You may not qualify if…

• Thyroid carcinoma of any histology or pheochromocytoma/paraganglioma
• Any of the following as this regimen may be harmful to a developing fetus or nursing child:
• Pregnant women
• Breastfeeding women
• Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
• NOTE: The effects of the agent(s) on the developing human fetus at the recommended therapeutic dose are unknown
• Anaplastic or high-grade histology
• Any of the following prior therapies:
• > 1 prior systemic chemotherapy regimen (chemoembolization not counted as systemic chemotherapy)
• Prior EGFR targeted regimen (e.g. OSI-774, EKB-569, ZD1839)
• < 4 weeks from last Interferon injection
• < 2 weeks from last octreatide short acting injection or < 6 weeks long acting injection; Note: concurrent octreatide allowed if stable dose has been administered for ≥1 month, there is documented tumor progression on the current dose, and there is no current plan for increasing dose • Other concurrent treatment considered investigational
• Concurrent chemotherapy or radiation therapy
• Any of the following:
• Gastrointestinal tract disease resulting in an inability to take oral medication (e.g. dysphagia or inability to swallow capsules intact).
• Requirement for IV alimentation
• Prior procedures clearly adversely affecting intestinal absorption
• Active peptic ulcer disease
• Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
• Known abnormality of cornea, such as:
• History of dry eye syndrome or Sjogren syndrome
• Congenital abnormality
• Abnormal slit-lamp examination using a vital dye (e.g.: fluorescein or Bengal-rose)
• Abnormal corneal sensitivity test (Schirmer test)
• Uncontrolled intercurrent illness including, but not limited to:

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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