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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00427349 (opens ClinicalTrials.gov in a new tab)Other idCDR0000526256Other idECOG-E4206Other idU10CA023318
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
46 participants (actual)
Sponsor
Eastern Cooperative Oncology Group · Network
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
7 Nov 2008
Primary completion
Oct 2014
Completion
Apr 2015
First posted
29 Jan 2007 (estimated)
Last update posted
5 Jul 2023
Conditions
Gastrointestinal Carcinoid Tumor · Islet Cell Tumor · Neoplastic Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082010201220142016
  1. Ph 2

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

    NCT00427349

    7 Nov 2008 to Apr 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • AMG 706Drug
  • octreotideDrug

Arms1

  • Experimental

    AMG 706+Octreotide

    Patients receive oral AMG 706 and octreotide acetate intramuscularly (IM) once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the morning. AMG 706 was taken daily without breaks in treatment. One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Four-month Progression-free Survival Rate

    Time frame · assessed every 4 weeks while on treatment and at three months post-treatment for participants treated for one cycle, up to month four

    Registry description

    Four-month progression-free survival (PFS) rate is defined as number of patients who are still progression free at 4 months after study entry divided by number of eligible and treated patients enrolled to the study. Progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), or unequivocal progression of existing non-target lesions.

Secondary outcomes(2)

  1. Overall Survival

    Time frame · assessed every 3 months if patient is < 2 years from study entry, then every 6 months up to 5 years

    Registry description

    Overall survival (OS) is defined as the time from registration until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method , with 95% confidence intervals calculated using Greenwood's formula

  2. Objective Response Rate

    Time frame · assessed every 8 weeks while on treatment, and frequency of tumor measurements during follow-up were determined by the treating physician, assessed up to 5 years

    Registry description

    Tumor response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by the total number of analyzable patients. CR is defined as complete disappearance of all tumor lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· assessed every 4 weeks while on treatment and at three months post-treatment for participants treated for one cycle, up to month four

Four-month Progression-free Survival Rate

GroupValue (percentage of participants)
AMG 706+Octreotide78.5
Secondary and other outcome results(2)
Secondary outcomeMedian· assessed every 3 months if patient is < 2 years from study entry, then every 6 months up to 5 years

Overall Survival

GroupValue (months)
AMG 706+Octreotide27.5
Secondary outcomeNumber· assessed every 8 weeks while on treatment, and frequency of tumor measurements during follow-up were determined by the treating physician, assessed up to 5 years

Objective Response Rate

GroupValue (percentage of participants)
AMG 706+Octreotide13.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
MG 706+OctreotideAMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment. Each cycle was defined as 28 days. AMG 706 was started within 7 working days of registration, given on the same day as the octreotide-LAR.–26 / 4543 / 45

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2018

E4206: AMG 706 and Octreotide in Patients with Low-Grade Neuroendocrine Tumors.

Lubner et al. 2018The oncologistcited by 6

PMID 29853660PMC6192662DOI 10.1634/theoncologist.2018-0294PUB-29853660

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Negative pregnancy test * Fertile patients must use effective contraception * Must be able to receive a contrast-enhanced CT scan * 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) * Aspartate aminotransferase (AST) ≤ 3 times ULN (5 times ULN if liver metastases are present) * Left Ventricular Ejection Fraction (LVEF) ≥ institutional lower limit of normal as evaluated by echocardiography or multigated acquisition (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 * 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 Exclusion criteria: * Prior procedures that would adversely affect intestinal absorption * Prior anti-vascular endothelial growth factors * Concurrent chemotherapy or radiation therapy * 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 * Arterial or venous thrombosis * Known history of allergic reactions to AMG 706 or derivatives or to octreotide acetate injections * 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) * Pregnant or nursing * Small cell lung cancer, medullary thyroid cancer, paraganglioma, or pheochromocytoma * Requirement for intravenous alimentation

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