Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Carcinoma

Adenocarcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Tyrosine Kinase Inhibitors

Enzyme Inhibitors

Gefitinib

Protein Kinase Inhibitors

Tyrosine

gefitinib

conventional surgery

enzyme inhibitor therapy

neoadjuvant therapy

protein tyrosine kinase inhibitor therapy

surgery

Kishan J. Pandya, MD

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.

OBJECTIVES:

Primary

* Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer.

Secondary

* Determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing until day -1. Patients undergo tumor resection on day 0.

After completion of study treatment, patients are followed periodically for 6 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery

A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer

University of Rochester

Symptoms and General Pathology

Gland and Hormone Related Diseases

Substance Related Disorders

Syndrome

Recurrence

Neuroendocrine Tumors

Carcinoid Tumor

Carcinoma, Islet Cell

Insulinoma

Gastrinoma

Glucagonoma

Somatostatinoma

Zollinger-Ellison Syndrome

Malignant Carcinoid Syndrome

Serotonin Syndrome

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Neuroendocrine Tumor

WDHA Syndrome

Carcinoid Syndrome

Neuroepithelioma

Pancreatic Cancer

Gastrointestinal Agents

Hormones

Somatostatin

Mitogens

Octreotide

Pancreatic Polypeptide

Vatalanib

Hormone Antagonists

Antineoplastic Agents, Hormonal

octreotide acetate

vatalanib

anti-cytokine therapy

antiangiogenesis therapy

biological therapy

endocrine therapy

growth factor antagonist therapy

hormone therapy

somatostatin analogue therapy

Kyle Holen, MD

Mary Mulcahy, MD

RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor. Octreotide may help control symptoms, such as diarrhea, caused by the tumor. Giving vatalanib together with octreotide may be an effective treatment for neuroendocrine tumors.

PURPOSE: This phase II trial is studying how well giving vatalanib together with octreotide works in treating patients with progressive neuroendocrine tumors.

OBJECTIVES:

* Determine the 4-month progression-free and overall survival of patients with progressive low-grade neuroendocrine tumors treated with vatalanib and octreotide.
* Determine the response rate in patients treated with this regimen.
* Determine the effect of this regimen on tumor markers (e.g., chromogranin A, 5-HIAA, and gastrin) in these patients.
* Determine the toxicity and tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral vatalanib once daily on days 1- 28 and octreotide\* intramuscularly or IV on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients on a stable dose (i.e., no changes in dosage within the past 3 months) of octreotide before study entry remain on their current dose and schedule during study participation; patients who experience hypersensitivity and/or toxicity to octreotide may receive vatalanib alone.

After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 3 years.

Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors

Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery	NCT00258297	Esophageal Canc...	gefitinib conventional su... enzyme inhibito... neoadjuvant the... protein tyrosin... surgery	18 Years -	University of Rochester
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors	NCT00227773	Gastrointestina... Islet Cell Carc...	octreotide acet... vatalanib anti-cytokine t... antiangiogenesi... biological ther... endocrine thera... enzyme inhibito... growth factor a... hormone therapy protein tyrosin... somatostatin an...	18 Years - 120 Years	Eastern Cooperative Oncology Group
Vatalanib and Octreotide in Treating Patients With Progressive Neuroendocrine Tumors	NCT00227773	Gastrointestina... Islet Cell Carc...	octreotide acet... vatalanib anti-cytokine t... antiangiogenesi... biological ther... endocrine thera... enzyme inhibito... growth factor a... hormone therapy protein tyrosin... somatostatin an...	18 Years - 120 Years	Eastern Cooperative Oncology Group

Spots Global Cancer Trial Database for protein tyrosine kinase inhibitor therapy