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

Neuroendocrine Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289741
• Other study ID #: 17-422
• Status: Completed
• Phase: Phase 4
• Start date: September 19, 2017
• Est. completion date: April 10, 2023

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering West Harrison	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

References & 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 f — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of mean pain scores	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center