Clinical trial NCT03289741: A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuroendocrine Tumors
Keywords: Octreotide
Lanreotide
17-422
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized design
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Mean Pain Scores at 3 Months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nitya Raj, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.