Octreotide Acetate before or after Lanreotide Acetate in Comparing Injection Site Pain in Patients with Locally Advanced or Metastatic Well Differentiated Neuroendocrine Tumors

Status: Active

Description

This randomized pilot phase IV trial studies octreotide acetate before or after lanreotide acetate in comparing injection site pain in patients with well differentiated neuroendocrine tumors that have spread from where they started to nearby tissue, lymph nodes, or other places in the body. Antihormone therapy, such as octreotide acetate and lanreotide acetate, may fight neuroendocrine tumors by blocking the use of hormones by the tumor cells.

Eligibility Criteria

Inclusion Criteria

  • Willing and able to provide written informed consent for the trial
  • Histologically- or cytologically- confirmed locally advanced or metastatic well differentiated neuroendocrine tumor (WDNET)
  • SSA therapy is recommended by physician for disease management, and has not yet begun
  • Eastern Cooperative Oncology Group (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

Locations & Contacts

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Nitya P. Raj
Phone: 646-888-4849
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Nitya P. Raj
Phone: 646-888-4849
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Nitya P. Raj
Phone: 646-888-4849

New York

Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Nitya P. Raj
Phone: 646-888-4849
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Nitya P. Raj
Phone: 646-888-4849
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Nitya P. Raj
Phone: 646-888-4849
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Nitya P. Raj
Phone: 646-888-4849

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare injection site pain experienced with octreotide acetate (octreotide long acting release [LAR]) and lanreotide acetate (lanreotide).

SECONDARY OBJECTIVES:

I. To evaluate if patients have a preference for octreotide LAR or lanreotide.

II. To evaluate patient willingness to pay for preferred somatostatin analog (SSA) therapy.

III. To quantify amount of time spent by nurses in clinic to prepare SSA injections.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive octreotide acetate intramuscularly (IM) once every 28 days for 3 months followed by lanreotide acetate deep subcutaneously (SC) once every 28 days for 3 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive lanreotide acetate deep SC once every 28 days for 3 months followed by octreotide acetate IM once every 28 days for 3 months in the absence of disease progression or unacceptable toxicity.

Trial Phase & Type

Trial Phase

Phase IV

Trial Type

Treatment

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Nitya P. Raj

Trial IDs

Primary ID 17-422
Secondary IDs NCI-2017-01844
Clinicaltrials.gov ID NCT03289741