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

NCT03289741 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-422
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Neuroendocrine Tumors

Keywords

Octreotide; Lanreotide; 17-422

Outcome Measures

Primary Outcomes (1)

• Mean Pain Scores at 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.

  3 months

Study Arms (2)

Octreotide then Lanreotide

EXPERIMENTAL

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; Drug: LAR Lanreotide; Behavioral: Questionnaires

Lanreotide then Octreotide

EXPERIMENTAL

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; Drug: LAR Lanreotide; Behavioral: Questionnaires

Interventions

Octreotide DRUG

Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections

Lanreotide then Octreotide; Octreotide then Lanreotide

LAR Lanreotide DRUG

Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections

Lanreotide then Octreotide; Octreotide then Lanreotide

Questionnaires BEHAVIORAL

Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.

Lanreotide then Octreotide; Octreotide then Lanreotide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering West Harrison

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Publications (1)

• Raj N, Cruz E, O'Shaughnessy S, Calderon C, Chou JF, Capanu M, Heffernan O, DeMore A, Punn S, Le T, Hauser H, Saltz L, Reidy-Lagunes D. A Randomized Trial Evaluating Patient Experience and Preference Between Octreotide Long-Acting Release and Lanreotide for Treatment of Well-Differentiated Neuroendocrine Tumors. JCO Oncol Pract. 2022 Sep;18(9):e1533-e1541. doi: 10.1200/OP.22.00055. Epub 2022 Jun 20.

  PMID: 35724357 RESULT

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Octreotide; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Nitya Raj, MD
• Organization: Memorial Sloan Kettering Cancer Center

rajn@mskcc.org

646-888-4849

Study Officials

• Nitya Raj, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm randomized design

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: September 19, 2017
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-01

Locations

US (7)