AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors (NCT00427349) | Clinical Trial Compass
CompletedPhase 2
AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
United States46 participantsStarted 2008-11-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 l…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Four-month Progression-free Survival Rate
Timeframe: assessed every 4 weeks while on treatment and at three months post-treatment for participants treated for one cycle, up to month four