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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00227773 |
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.
Condition | Intervention | Phase |
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Gastrointestinal Carcinoid Tumor Islet Cell Carcinoma |
Drug: octreotide acetate Drug: vatalanib Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological therapy Procedure: endocrine therapy Procedure: enzyme inhibitor therapy Procedure: growth factor antagonist therapy Procedure: hormone therapy Procedure: protein tyrosine kinase inhibitor therapy Procedure: somatostatin analogue therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Vatalanib and Octreotide in Patients With Progressive Low-Grade Neuroendocrine Tumors |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study ID Numbers: | CDR0000446076, ECOG-E6203 |
Study First Received: | September 26, 2005 |
Last Updated: | October 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00227773 |
Health Authority: | United States: Federal Government |
localized gastrointestinal carcinoid tumor metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor recurrent islet cell carcinoma gastrinoma |
insulinoma WDHA syndrome glucagonoma pancreatic polypeptide tumor somatostatinoma |
Gastrointestinal Diseases Pancreatic Neoplasms Pancreatic Polypeptide Octreotide Vatalanib Neoplasms, Germ Cell and Embryonal Neuroepithelioma Endocrine Gland Neoplasms Digestive System Neoplasms Carcinoma, Islet Cell Serotonin Syndrome Insulinoma Endocrine System Diseases Malignant Carcinoid Syndrome Carcinoid syndrome |
Somatostatin Recurrence Neuroendocrine Tumors Carcinoma Carcinoid tumor Neuroectodermal Tumors Gastrinoma Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Carcinoid Tumor Endocrinopathy Adenocarcinoma Pancreatic islet cell tumors Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Hormones Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |