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NCT02795858 Clinical Trial - National Cancer Institute || Ramucirumab and Somatostatin Analog Therapy in Treating Patients with Locally Advanced or Metastatic Carcinoid Tumor That Cannot Be Removed by Surgery
Ramucirumab and Somatostatin Analog Therapy in Treating Patients with Locally Advanced or Metastatic Carcinoid Tumor That Cannot Be Removed by Surgery
Basic Trial Information
18 and over
16-072 NCI-2016-00941, NCT02795858
This phase II trial studies how well ramucirumab and somatostatin analog therapy work in treating patients with carcinoid tumor that has spread from where it started or cannot be removed by surgery. Monoclonal antibodies, such as ramucirumab, may block tumor growth in different ways by targeting certain cells and may also block the growth of new blood vessels necessary for tumor growth. Somatostatin analog therapy may slow down tumor growth and control the symptoms of carcinoid syndrome. Giving ramucirumab and somatostatin analog therapy may work better in treating patients with carcinoid tumor.
Further Study Information
I. To assess the progression-free survival duration of patients with advanced, progressive carcinoid tumors treated with ramucirumab in combination with somatostatin analog therapy.
I. To determine the safety and tolerability of ramucirumab in combination with somatostatin analog therapy in patients with advanced carcinoid tumors.
II. To assess the overall radiographic and biochemical response rate associated with ramucirumab in combination with somatostatin analog therapy in patients with advanced carcinoid tumors.
III. To assess the overall survival duration of patients with advanced, progressive carcinoid tumors treated with ramucirumab in combination with somatostatin analog therapy.
Patients receive ramucirumab intravenously (IV) over 1 hour on days 1 and 15 and somatostatin analog therapy according to institutional guidelines. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks or 6 months.
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 computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
Locally advanced, unresectable or metastatic disease
Patients must have evidence of radiographic disease progression within the past 12 months; progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria is not required
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Absolute neutrophil count >= 1,000/mm^3
Platelets >= 100,000/mm^3
Hemoglobin >= 9 g/dL
Total bilirubin =< 1.5 x institutional upper limit of normal
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional upper limit of normal, or =< 5 x institutional upper limit of normal in the setting of liver metastases
Creatinine =< 1.5 x 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 demonstrate < 1000 mg of protein in 24 hours)
Adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal; patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of ramucirumab administration
Ability to understand and the willingness to sign a written informed consent document
Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Patients who have undergone major surgery within 28 days or subcutaneous venous access device placement within 7 days prior to study enrollment
Patients with elective or planned major surgery to be performed during the course of the clinical trial
Patients who are receiving any other investigational agents
Patients with any grade 3-4 gastrointestinal bleeding within 3 months prior to enrollment
Patients with a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered “significant”) during the 3 months prior to registration
Patients who have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment
Patients with uncontrolled or poorly-controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management
Patients who have congestive heart failure (New York Heart Association [NYHA] class III or IV), sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block within the six months preceding enrollment
Patients who have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis
Patients with a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment
Patients receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin use (maximum dose 325 mg/day) is permitted
Patients with uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years
Patients with symptomatic cholelithiasis
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Severely impaired lung function
Any active (acute or chronic) or uncontrolled infection/disorders
Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
Psychiatric illness/social situations that would limit compliance with study requirement
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ramucirumab
Pregnant and breastfeeding women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ramucirumab
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.
ver historia personal en: www.cerasale.com.ar [dado de baja por la Cancillería Argentina por temas políticos, propio de la censura que rige en nuestro medio]//
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weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - //
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