A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progr… (NCT02795858) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors
United States43 participantsStarted 2016-06-14
Plain-language summary
This research study is evaluating the drug Ramucirumab as a possible treatment for Advanced, Progressive Carcinoid 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:
* Participants must have histologically or cytologically confirmed low- to intermediate-grade neuroendocrine tumor (carcinoid tumor).
* Carcinoid tumors of any site are eligible. Patients with pancreatic neuroendocrine tumors are excluded.
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 10 for the evaluation of measurable disease.
* Locally advanced, unresectable or metastatic disease.
* Patients must have evidence of radiographic disease progression within the past 12 months. Progressive disease by RECIST criteria is not required.
* Age ≥ 18 years.
* ECOG performance status 0-1 (see Appendix A).
* Participants must have normal organ and marrow function as defined below:
* absolute neutrophil count ≥1,000/ mm3
* platelets ≥100,000/ mm3
* hemoglobin ≥ 9 g/dL
* total bilirubin ≤ 1.5 × institutional upper limit of normal
* AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal, or ≤ 5× institutional upper limit of normal in the setting of liver metastases
* creatinine ≤ 1.5 × upper limit of normal
* urinary protein ≤ 1+ on dipstick or routine urinalysis (if urine dipstick or routine urinalysis is 2+, a 24-hour urine collection for protein must dem…
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: Survival collected every 12 weeks in long-term follow-up. The median survival follow-up time was 23.5 months (range 1.7 - 76.6 months)