A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide

Phase 4

Completed

Interventions: Drug: Octreotide
Drug: LAR Lanreotide
Behavioral: Questionnaires

Brief Summary: This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.

Recruitment & Eligibility

Inclusion Criteria

Willing and able to provide written informed consent for the trial
≥ 18 years of age
Histologically- or cytologically- confirmed locally advanced or metastatic WDNET
SSA therapy is recommended by physician for disease management, and has not yet begun
ECOG performance status of 0, 1, or 2

Exclusion Criteria

Currently participating in a study of an investigational agent
Prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

*Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study
No concurrent chemotherapy or targeted small molecule therapy
If received major surgery, not recovered adequately from the toxicity and/or complications from the intervention prior to starting the study
Known additional malignancy that is progressing or requires active treatment
Active infection requiring systemic therapy
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Arm && Interventions

Group	Intervention	Description
Octreotide then Lanreotide	LAR Lanreotide	Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections
Octreotide then Lanreotide	Questionnaires	Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections
Lanreotide then Octreotide	Questionnaires	Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
Lanreotide then Octreotide	LAR Lanreotide	Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
Octreotide then Lanreotide	Octreotide	Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections
Lanreotide then Octreotide	Octreotide	Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections

Primary Outcome Measures

Name	Time	Method
Mean Pain Scores at 3 Months	3 months	Patients will rate, on a numeric scale of 0 to 10, with 0 being No pain" to 10 being "Worst pain ever" the pain or discomfort experienced with the SSA injection.

Secondary Outcome Measures

Name	Time	Method

Locations (7): Memorial Sloan Kettering Commack
🇺🇸
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Memorial Sloan Kettering West Harrison
🇺🇸
Harrison, New York, United States
Memorial Sloan Kettering Nassau
🇺🇸
Uniondale, New York, United States
Memorial Sloan Kettering Monmouth
🇺🇸
Middletown, New Jersey, United States
Memorial Sloan Kettering Basking Ridge
🇺🇸
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen
🇺🇸
Montvale, New Jersey, United States