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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: | NCT00427349 |
RATIONALE: AMG 706 and octreotide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well AMG 706 and octreotide work in treating patients with low-grade neuroendocrine tumors.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Carcinoid Tumor Islet Cell Tumor Neoplastic Syndrome |
Drug: motesanib diphosphate Drug: octreotide acetate Procedure: computed tomography Procedure: gene expression analysis Procedure: laboratory biomarker analysis Procedure: protein expression analysis Procedure: reverse transcriptase-polymerase chain reaction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Clinical and Biologic Study of AMG 706 and Octreotide in Patients With Low-Grade Neuroendocrine Tumors |
Estimated Enrollment: | 44 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Plasma samples are collected at baseline, periodically during study treatment, and at 4 weeks after the completion of study treatment. Samples are used to determine plasma vascular endothelial growth factor (VEGF) levels. Gene expression of downstream markers of Raf kinase expression (raf, MEK, and ERK) as well as HASH1 and Notch1 are evaluated at baseline. Tumor tissue collected at diagnosis or prior surgery is examined by reverse transcriptase-polymerase chain reaction assay. Contrast CT scans are conducted at baseline, day 2 of course 1, and week 8 to assess tumor perfusion.
After the completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Radiographic evidence of disease progression after any prior systemic therapy, chemoembolization, bland embolization, or observation, defined by either of the following:
PATIENT CHARACTERISTICS:
No history of uncontrolled hypertension (resting blood pressure > 150/90 mm Hg)
No history of the following within the past 12 months:
PRIOR CONCURRENT THERAPY:
One prior systemic chemotherapy regimen for low-grade neuroendocrine neoplasm allowed
Study Chair: | Kyle D. Holen, MD | University of Wisconsin, Madison |
Investigator: | Mary Mulcahy, MD | Robert H. Lurie Cancer Center |
Investigator: | Peter J. O'Dwyer, MD, BCh | University of Pennsylvania |
Study ID Numbers: | CDR0000526256, ECOG-E4206 |
Study First Received: | January 25, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00427349 |
Health Authority: | Unspecified |
gastrinoma localized gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor metastatic gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor insulinoma |
WDHA syndrome glucagonoma pancreatic polypeptide tumor somatostatinoma recurrent islet cell carcinoma |
Gastrointestinal Diseases Pancreatic Neoplasms Pancreatic Polypeptide Octreotide Neoplasms, Germ Cell and Embryonal Neuroepithelioma Endocrine Gland Neoplasms Digestive System Neoplasms Carcinoma, Islet Cell Serotonin Syndrome Insulinoma Endocrine System Diseases Adenoma, Islet Cell Malignant Carcinoid Syndrome Carcinoid syndrome |
Recurrence Neuroendocrine Tumors Carcinoma Carcinoid tumor Neuroectodermal Tumors Gastrinoma Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Carcinoid Tumor Endocrinopathy Adenocarcinoma Adenoma Pancreatic islet cell tumors Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Pathologic Processes Disease Neoplasms by Histologic Type Antineoplastic Agents, Hormonal |
Antineoplastic Agents Therapeutic Uses Syndrome Neoplasms, Nerve Tissue Gastrointestinal Agents Pharmacologic Actions |