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AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00427349
First received: January 25, 2007
Last updated: July 18, 2012
Last verified: March 2010

January 25, 2007
July 18, 2012
September 2008
November 2012   (final data collection date for primary outcome measure)
  • Time to progression [ Designated as safety issue: No ]
  • Progression-free survival at 4 months [ Designated as safety issue: No ]
  • Time to progression
  • Progression-free survival at 4 months
Complete list of historical versions of study NCT00427349 on ClinicalTrials.gov Archive Site
  • Objective response (complete or partial response, progressive disease, or stable disease) as measured by RECIST criteria [ Designated as safety issue: No ]
  • Toxicity and tolerability [ Designated as safety issue: Yes ]
  • Effect of AMG 706 on markers in tumor cells [ Designated as safety issue: No ]
  • Objective response (complete or partial response, progressive disease, or stable disease) as measured by RECIST criteria
  • Toxicity and tolerability
  • Effect of AMG 706 on markers in tumor cells, including VEGF, VEGFR-2, chromogranin A, human achaetescute homolog-1, and Notch1
Not Provided
Not Provided
 
AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
A Phase II Clinical and Biologic Study of AMG 706 and Octreotide in Patients With Low-Grade Neuroendocrine Tumors

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.

OBJECTIVES:

Primary

  • Determine the 4-month progression-free survival (PFS) of patients with low-grade neuroendocrine tumors treated with AMG 706 and octreotide acetate.

Secondary

  • Determine the response rate and overall survival of patients treated with these drugs.
  • Determine the toxicity and tolerability of AMG 706 in these patients.
  • Determine the effect of AMG 706 on tumor perfusion by functional CT scan.
  • Determine the effect of AMG 706 on tumor markers (e.g., chromogranin A, 5-hydroxyindoleacetic acid, and gastrin) specific for neuroendocrine tumors.
  • Determine the effect of AMG 706 on serum vascular endothelial growth factor (VEGF) levels.
  • Determine the expression of VEGF, VEGF receptor-2 (VEGFR-2), chromogranin A, human achaetescute homolog-1, and Notch1 markers of neuroendocrine tumors.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Gastrointestinal Carcinoid Tumor
  • Islet Cell Tumor
  • Neoplastic Syndrome
  • Drug: motesanib diphosphate
  • Drug: octreotide acetate
  • Genetic: gene expression analysis
  • Genetic: protein expression analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: laboratory biomarker analysis
  • Procedure: computed tomography
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
44
Not Provided
November 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed low-grade neuroendocrine neoplasm
  • Measurable disease
  • Radiographic evidence of disease progression after any prior systemic therapy, chemoembolization, bland embolization, or observation, defined by either of the following:

    • Appearance of a new lesion
    • At least 20% increase in the longest diameter of any previously documented lesion or in the sum of the longest diameters of multiple lesions
  • Tissue block from original diagnostic or surgical specimen required
  • Concurrent stable-dose octreotide acetate required
  • No small cell lung cancer, medullary thyroid cancer, paraganglioma, or pheochromocytoma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be able to receive a contrast-enhanced CT scan
  • No known history of allergic reactions to AMG 706 or derivatives or to octreotide acetate injections
  • No gastrointestinal tract disease resulting in an inability to take oral medication (i.e., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, bowel obstruction, or inability to swallow tablets)
  • No requirement for IV alimentation
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin level ≥ 8.0 g/dL
  • Bilirubin ≤ 2.0 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN (5 times ULN if liver metastases are present)
  • LVEF ≥ institutional lower limit of normal as evaluated by echocardiography or MUGA scan
  • No history of uncontrolled hypertension (resting blood pressure > 150/90 mm Hg)

    • Antihypertensive medications allowed if patients is stable on their current dose
  • No history of the following within the past 12 months:

    • New York Heart Association class III or IV congestive heart failure
    • Unstable angina pectoris
    • Myocardial infarction
    • Symptomatic cardiac arrhythmia
    • Cerebrovascular accident or transient ischemic attack
  • No history of arterial or venous thrombosis within the past 12 months

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • One prior systemic chemotherapy regimen for low-grade neuroendocrine neoplasm allowed

    • Chemoembolization is not considered systemic chemotherapy
  • At least 4 weeks since prior major surgery, chemotherapy, radiation therapy, other systemic therapy, or local liver therapy
  • No prior procedures that would adversely affect intestinal absorption
  • No prior anti-vascular endothelial growth factors
  • No concurrent chemotherapy or radiation therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00427349
CDR0000526256, ECOG-E4206
Not Provided
Robert L. Comis, ECOG Group Chair's Office
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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 Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP