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 range18 Years
SexALL
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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…
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