Gefitinib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

NCT00075439 | Completed Phase 2

• 3 other identifiers: NCI-2012-02796MC0279N01CM62205
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrinoma; Glucagonoma; Insulinoma; Metastatic Gastrointestinal Carcinoid Tumor; Pancreatic Polypeptide Tumor; Recurrent Gastrointestinal Carcinoid Tumor; Recurrent Islet Cell Carcinoma; Somatostatinoma; WDHA Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of patients progression-free at 6 months

  If patients are lost to follow-up or discontinue active monitoring prior to 6 months post-registration, we will consider censoring them for the evaluation of the primary endpoint. Here, Kaplan-Meier methodology will be used to estimate the final success proportion (ie, 6 month success rate with a 95% confidence interval). Otherwise, ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

  At 6 months

Secondary Outcomes (6)

• Incidence of adverse events graded according to NCI CTCAE version 3.0

  Up to 2 years

• Confirmed tumor response to treatment will be evaluated and will be considered a PR or CR on consecutive evaluations at least 4 weeks apart

  Up to 2 years

• Survival time

  Time from registration to death due to any cause, assessed up to 2 years

• Time to disease progression

  Time from randomization to documentation of disease progression, assessed up to 2 years

• Duration of response

  Date from which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 2 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: gefitinib; Other: laboratory biomarker analysis

Interventions

gefitinib DRUG

Given orally

Also known as: Iressa, ZD 1839

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

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).

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Gastrinoma; Glucagonoma; Insulinoma; Carcinoma, Islet Cell; Somatostatinoma; Vipoma

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenoma, Islet Cell; Adenoma; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Timothy Hobday

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 12, 2004
• Study Start: December 1, 2003
• Primary Completion: May 1, 2007
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)