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An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Islet Cell Carcinoma, Neuroendocrine Carcinoma, Neuroendocrine Tumor, Pancreatic Neoplasms

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Trial Information

An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy


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 cytotoxic chemotherapy.

Stratum 1, consisted of patients not receiving chronic Octreotide Depot therapy, will
receive everolimus monotherapy at 10 mg/day.

Stratum 2, consisting of patients with tumors that have progressed during Octreotide Depot
treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mg/day.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.

Outcome Time Frame:

from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2239

NCT ID:

NCT00363051

Start Date:

June 2006

Completion Date:

April 2012

Related Keywords:

  • Islet Cell Carcinoma
  • Neuroendocrine Carcinoma
  • Neuroendocrine Tumor
  • Pancreatic Neoplasms
  • Pancreatic
  • Tumor
  • Islet Cell
  • Carcinoma
  • Neuroendocrine
  • Endocrine
  • Atypical Carcinoid
  • RADIANT1
  • RADIANT-1
  • Neoplasms
  • Carcinoma
  • Pancreatic Neoplasms
  • Carcinoma, Neuroendocrine
  • Neuroendocrine Tumors
  • Carcinoma, Islet Cell

Name

Location

The University of Alabama at BirminghamBirmingham, Alabama  35294
Mayo ClinicRochester, Minnesota  55905
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Duke University Medical CenterDurham, North Carolina  27710
University of Wisconsin Hospital & ClinicsMadison, Wisconsin  53792
UCLA Medical CenterLos Angeles, California  90095-7059
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Scott & White Memorial HospitalTemple,, Texas  76508
University of MiamiMiami, Florida  33136
Oregon Health and Science UniversityPortland, Oregon  97201
Emory University HospitalAtlanta, Georgia  30322
Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.Los Angeles, California  90048
USC Medical CenterLos Angeles, California  90033
H. Lee Moffit Cancer Center & Research InstituteTampa, Florida  33612
LSUHC Multispecialty ClinicNew Orleans, Louisiana  70115
Lynn Ratner, M.D.New York, New York  10028
Arthur G. James Cancer Hospital/Ohio State UniversityColumbus, Ohio  43210
M. D Anderson Cancer CenterHouston, Texas  77030