Switching From Octreotide to Lanreotide - A Look Back at Patients With Neuroendocrine Tumors
Study Details
Study Description
Brief Summary
The purpose of this study is to understand how people with neuroendocrine tumors respond to treatment with lanreotide after having received treatment with octreotide.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Response to treatment [4 months (data collection duration)]
Evaluated as responsive disease (i.e., complete response, partial response), stable disease or progressive disease at the last tumor assessment while on treatment with lanreotide (based on tumor imaging, symptoms, biomarker(s) and/or clinical judgement)
Secondary Outcome Measures
- Progression-free survival, after treatment with octreotide [4 months (data collection duration)]
For evaluating progression-free survival events will include radiographic progression per investigator, biomarker progression per investigator, symptom progression per investigator, and death. Adverse events (AEs) will not be considered as an event.
- Duration of response to lanreotide, after treatment with octreotide [4 months (data collection duration)]
For evaluating duration of response events will include radiographic progression per investigator, biomarker progression per investigator, symptom progression per investigator, AEs, and death. Open ended responses will be reviewed during the analysis and determined to be an eligible "event" or not at that time.
- Duration of treatment with octreotide and duration of treatment with lanreotide [4 months (data collection duration)]
Duration of octreotide treatment assessed as time from start of octreotide treatment to stop of octreotide treatment. Duration of lanreotide treatment assessed as time from lanreotide initiation to end of lanreotide treatment (censored at the date of last administration (+lanreotide frequency) for patients who had ongoing lanreotide treatment).
- Severity of Adverse Events [4 months (data collection duration)]
Summarized separately during treatment with octreotide and during treatment with lanreotide, as available
- Reasons for switching from octreotide to lanreotide [4 months (data collection duration)]
Summarized descriptively
- Levels of 5-hydroxyindoleacetic acid (5-HIAA) (urine test or blood test) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available [4 months (data collection duration)]
Summarized descriptively
- Levels of Chromogranin A (CgA) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available [4 months (data collection duration)]
Summarized descriptively
- Severity of symptoms (i.e., flushing, diarrhea, dyspnea, abdominal pain, edema, nausea) before treatment with octreotide, during treatment with octreotide, and during treatment with lanreotide, as available [4 months (data collection duration)]
Proportion of patients reporting each symptom
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males and females age 18 years or older at time of locally advanced or metastatic diagnosis
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Patients with a confirmed diagnosis of locally advanced or metastatic Gastroenteropancreatic neuroendocrine tumour (GEP-NET)
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Patients who switched treatment from long acting octreotide LAR to lanreotide, where both treatments were received for the treatment of locally advanced or metastatic GEP-NET. i. Treatment with long acting octreotide LAR monotherapy for at least 90-days before treatment with lanreotide monotherapy (rescue SSA# use permitted). ii. Treatment with lanreotide monotherapy for at least 90-days after treatment with long acting octreotide monotherapy (rescue SSA# use permitted)
Exclusion Criteria:
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Patients with other malignant disease
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Patients who participated in a concomitant clinical trial related to treatment of GEP-NET
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Patients being treated with a Somatostatin analogue (SSA) in combination with other NET treatments excluding rescue SSA#
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Patients who received other primary treatment (e.g., targeted therapy, chemotherapy) for GEP-NET during the interval between octreotide and lanreotide
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Patients with NET familial genetic syndrome (i.e., MEN1)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 2 | Cancer Center of Kansas | Wichita | Kansas | United States | 67214 |
| 3 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 4 | Mercy Medical Center | Baltimore | Maryland | United States | 21202 |
| 5 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 6 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 7 | National Transitional Research | East Setauket | New York | United States | 11733 |
| 8 | Allegheny Cancer Center | Pittsburgh | Pennsylvania | United States | 15212 |
Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A-US-52030-364