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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00227773 |
Purpose
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 |
|---|---|---|
|
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: | Primary Purpose: 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.
Eligibility| 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
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00227773 History of Changes |
| Other Study ID Numbers: | CDR0000446076, ECOG-E6203 |
| Study First Received: | September 26, 2005 |
| Last Updated: | October 24, 2006 |
| 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 |
|
Carcinoid Tumor Carcinoma Neuroendocrine Tumors Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Carcinoma, Islet Cell Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Pancreatic Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Enzyme Inhibitors Vatalanib Mitogens Hormones Somatostatin Octreotide Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Mitosis Modulators |