Octreotide Acetate before or after Lanreotide Acetate in Comparing Injection Site Pain in Patients with Locally Advanced or Metastatic Well Differentiated Neuroendocrine Tumors
- 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
- 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
I. To compare injection site pain experienced with octreotide acetate (octreotide long acting release [LAR]) and lanreotide acetate (lanreotide).
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 Phase IV
Trial Type Treatment
Memorial Sloan Kettering Cancer Center
Nitya P. Raj
- Primary ID 17-422
- Secondary IDs NCI-2017-01844
- Clinicaltrials.gov ID NCT03289741