Phase II Study of Pasireotide LAR in Patients With Metastatic Neuroendocrine Carcinomas
The goal of this clinical research study is to learn if the study drug, Pasireotide LAR can shrink or slow the growth of Metastatic Neuroendocrine Carcinomas. The safety of this drug will also be studied. The patient's physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and effective.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Pasireotide Long Acting Release (LAR)
Phase: Phase 2
Ages Eligible For Study:
- Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors - Tumors must be considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study. - No prior systemic antineoplastic neuroendocrine tumor treatment (including prior somatostatin analogs). However patients who have received a short course of subcutaneous (SQ) octreotide (<10 days) in the past are eligible if > 1 week has elapsed from their last octreotide injection. - Minimum of four weeks since any major surgery - Measureable disease by Response Evaluation Criteria in Solid Tumors (RECIST) - Eastern Cooperative Oncology Group (ECOG) performance status ?1 - Life expectancy 12 weeks or more - Adequate bone marrow function as shown by: absolute neutrophil count (ANC) ? 1.0 x 10^9/L, Platelets ? 75 x 10^9/L, hemoglobin (Hgb) > 8 g/dL - Adequate liver function as shown by: serum bilirubin ? 2.0 x upper limit of normal (ULN), and serum transaminases activity ? 2 x ULN, with the exception of serum transaminases (< 3 x ULN) if the patient has liver metastases - Adequate renal function as shown by serum creatinine ? 2.0 x ULN - Fasting serum cholesterol ?300 mg/dL OR ?7.75 mmol/L AND fasting triglycerides ? 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication. - Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating. Both men and WOCBP must be advised of the importance of using effective birth control measures during the course of the study. - Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.