Neuroendocrine Tumors
Conditions
Keywords
Octreotide, Lanreotide, 17-422
Brief summary
This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.
Interventions
DRUGOctreotide
Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections
DRUGLAR Lanreotide
Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
BEHAVIORALQuestionnaires
Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm randomized design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Scores at 3 Months | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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
Questionnaires: Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary. | 26 |
| 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
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
Questionnaires: Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary. | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Physician Decision | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Octreotide Then Lanreotide | Total | Lanreotide Then Octreotide |
|---|---|---|---|
| Age, Continuous | 63 years | 65 years | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 44 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 21 Participants | 40 Participants | 19 Participants |
| Region of Enrollment United States | 26 Participants | 51 Participants | 25 Participants |
| Sex: Female, Male Female | 11 Participants | 26 Participants | 15 Participants |
| Sex: Female, Male Male | 15 Participants | 25 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 51 | 8 / 51 |
| other Total, other adverse events | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 13 / 51 | 8 / 51 |
Outcome results
Primary
Mean Pain Scores at 3 Months
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.
Time frame: 3 months
Population: The mean pain scores for each treatment arm is appropriately reported below.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Octreotide Then Lanreotide | Mean Pain Scores at 3 Months | Octreotide, first intervention (3 months) | 2.4 scores on a scale |
| Octreotide Then Lanreotide | Mean Pain Scores at 3 Months | Lanreotide, second intervention (6 months) | 2.4 scores on a scale |
| Lanreotide Then Octreotide | Mean Pain Scores at 3 Months | Lanreotide, first intervention (3 months) | 1.9 scores on a scale |
| Lanreotide Then Octreotide | Mean Pain Scores at 3 Months | Octreotide, second intervention (6 months) | 1.9 scores on a scale |