Status:
COMPLETED
Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Islet Cell Carcinoma
Neuroendocrine Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients ...
Detailed Description
This was a stratified two-stage, single-arm, phase 2 study of treatment with everolimus in patients with advanced (unresectable or metastatic) pancreatic neuroendocrine tumor (NET) after failure of cy...
Eligibility Criteria
Inclusion
- Inclusion criteria for both strata:
- Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor (NET)
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Objective disease progression by Response Evaluation Criteria in Solid tumors (RECIST) criteria while receiving cytotoxic chemotherapy or at any time after receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive cycles or months of treatment with the same cytotoxic drug or regimen)
- Presence of at least one measurable disease using RECIST criteria at screening (computer tomography \[CT\] or Magnetic resonance imaging \[MRI\])
- Adequate bone marrow, liver and kidney function
- WHO Performance Status 0-2.
- Inclusion criteria for Stratum 2 only:
- Meet all inclusion criteria defined above for both strata.
- Receiving treatment (at least 3 consecutive months) with Octreotide Depot.
- In addition to documentation of progressive disease on or after chemotherapy, patients in stratum 2 must have documented objective progression of disease while receiving Octreotide Depot.
- Exclusion criteria for both strata:
- Anticancer therapy within 3 weeks of enrollment.
- Patients with poorly differentiated neuroendocrine carcinoma
- Hepatic artery embolization within the last 6 months
- Prior therapy with everolimus or other rapamycins (sirolimus, temsirolimus)
- Other concurrent malignancy
- Other serious intercurrent infections or nonmalignant uncontrolled medical illnesses
- Exclusion Criterion for Stratum 1 only:
- • Received treatment with Octreotide Depot or any other long-acting somatostatin analogue in the 60 days prior to enrollment or any short-acting somatostatin analogue in the two weeks prior to enrollment.
- Other protocol-defined inclusion/exclusion criteria applied.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00363051
Start Date
June 1 2006
End Date
April 1 2012
Last Update
May 10 2013
Active Locations (54)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
USC Medical Center
Los Angeles, California, United States, 90033
3
Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.
Los Angeles, California, United States, 90048
4
UCLA Medical Center
Los Angeles, California, United States, 90073