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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 4

Conditions: Neuroendocrine Tumors

Treatments: Drug: LAR Lanreotide; Behavioral: Questionnaires; Drug: Octreotide

Study type: Interventional

Funder types: Other

Identifiers

NCT03289741

17-422

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Octreotide then Lanreotide

Experimental group

Description:

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

Treatment:

Drug: Octreotide

Behavioral: Questionnaires

Drug: LAR Lanreotide

Lanreotide then Octreotide

Experimental group

Description:

Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections

Treatment:

Drug: Octreotide

Behavioral: Questionnaires

Drug: LAR Lanreotide