Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome
18 Years
N/A
Both
Neuroendocrine Carcinoma
Trial Information
Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome
The study population will consist of patients with advanced (metastatic or unresectable)
neuroendocrine tumors with suboptimally controlled carcinoid syndrome. While the majority of
patients will have primary tumors of the ileocecum (midgut), any serotonin-producing
neuroendocrine tumors will be eligible (including pancreatic, lung and unknown primary).
All patients will be followed for adverse events and serious adverse events for 28 days
following the last dose of above-label octreotide, or until resolution or stabilization of
the event, whichever comes first.
Inclusion Criteria:
- Metastatic neuroendocrine tumors that are considered well or moderately
differentiated (or low to intermediate grade). Patients with poorly differentiated
neuroendocrine carcinomas or small cell carcinomas are excluded from the study.
- Elevated urine 5-hydroxyindoleacetic acid (5-HIAA).
- More than 2 bowel-movements per day OR more than 4 flushing episodes per week on
average.
- Patient currently on octreotide LAR 30mg every 3 or 4 weeks (for at least 3 cycles
prior to screening).
- Age ≥ 18 years.
- Minimum of four weeks since any major surgery, liver-directed therapy (embolization,
etc.) or systemic cancer treatment other than octreotide LAR.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Life expectancy > 12 weeks.
- Reliable contraception should be maintained throughout the study and for 3 months
after study drug discontinuation.
- Signed informed consent to participate in the study must be obtained from patients
after they have been fully informed of the nature and potential risks by the
investigator (or his/her designee) with the aid of written information.
Exclusion Criteria:
- Patients with poorly differentiated neuroendocrine cancers.
- Patients with symptomatic cholelithiasis.
- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study.
- History of noncompliance to medical regimens or unwillingness to comply with the
protocol.
- Patients who were unable to tolerate or did not benefit from above-label dose
octreotide (>30mg) in the past.
- Concomitant use of other cancer treatments or carcinoid syndrome treatments (whether
standard or experimental). Patients should discontinue any concomitant cancer
medications more than two weeks prior to screening.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Frequency of Symptoms
Outcome Description:
The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared. These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank test controlling type I error at 0.05 based on 2000 Monte Carlo simulations.
Outcome Time Frame:
Up to 5 years
Safety Issue:
No
Principal Investigator
Jonathan Strosberg, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
MCC-17410
NCT ID:
NCT01886287
Start Date:
August 2013
Completion Date:
April 2018
Related Keywords:
- Neuroendocrine Carcinoma
- endocrine system
- neuroendocrine tumors
- neuroendocrine cancer
- metastatic
- neuroendocrine
- gastrointestinal (GI)
- high-dose octreotide
- flushing
- diarrhea
- quality of life in patients
- disease-related symptoms
- Carcinoid Tumor
- Carcinoma
- Malignant Carcinoid Syndrome
- Serotonin Syndrome
- Carcinoma, Neuroendocrine
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
