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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03289741
• Collaborator: (none)
• Enrollment: 53
• Locations: 7
• Arms: 2
• Anticipated Duration (Months): 83.4
• Patients Per Site: 7.6
• Patients Per Site Per Month: 0.1

Study Details

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
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Two-arm randomized designTwo-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: Sep 19, 2017
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
5	Memorial Sloan Kettering West Harrison	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT03289741
• Other Study ID Numbers: 17-422
• First Posted: Sep 21, 2017
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• 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; Octreotide; Lanreotide

Study Results

No Results Posted as of Apr 21, 2022