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

• ClinicalTrials.gov Identifier: NCT03289741
• Recruitment Status: Completed
• First Posted: September 21, 2017
• Last Update Posted: April 12, 2023
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Neuroendocrine Tumors	Drug: Octreotide; Drug: LAR Lanreotide; Behavioral: Questionnaires	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Two-arm randomized design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study To Evaluate Patient Experience With the Somatostatin Analogs Octreotide Long Acting Release and Lanreotide During the Treatment of Advanced, Nonfunctional, Well Differentiated Neuroendocrine Tumors
• Actual Study Start Date: September 19, 2017
• Actual Primary Completion Date: April 10, 2023
• Actual Study Completion Date: April 10, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Octreotide then 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	Drug: Octreotide; Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections; Drug: LAR Lanreotide; Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections; Behavioral: Questionnaires; Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.
Experimental: Lanreotide then 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	Drug: Octreotide; Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections; Drug: LAR Lanreotide; Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections; Behavioral: Questionnaires; Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.

Outcome Measures

Primary Outcome Measures :

1. Comparison of mean pain scores [ Time Frame: 2 years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States, 07920

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States, 07748

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

United States, New York

Memorial Sloan Kettering Commack

Commack, New York, United States, 11725

Memorial Sloan Kettering West Harrison

Harrison, New York, United States, 10604

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Nitya Raj, MD; Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center 

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT03289741
• Other Study ID Numbers: 17-422
• First Posted: September 21, 2017
• Last Update Posted: April 12, 2023
• Last Verified: April 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Memorial Sloan Kettering Cancer Center:

Octreotide; Lanreotide; 17-422

Additional relevant MeSH terms:

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Octreotide; Lanreotide; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents