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EPO906 in Carcinoid and Other Neuroendocrine Tumors

Primary Purpose

Carcinoid, Neuroendocrine Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EPO906 epothilone B
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoid focused on measuring cancer, tumor, tumour, neoplasm, carcinoma, carcinoid, neuroendocrine, Islet cell, Gastrinoma, VIPoma, metastatic, intravenous, epothilone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with biopsy-proven metastatic carcinoid tumors or other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas) with at least one measurable lesion (other than bone) that has either not been previously irradiated or if previously irradiated has demonstrated progression since the radiation therapy The patient has no major impairment of renal or hepatic function, as defined by the following laboratory parameters: total bilirubin <1.5 X ULN; AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present) Patients on Sandostatin Lar (long acting somatostatin analogue) must be on a stable dose for 30 days prior to study entry and short acting somatostatin analogues must be judged to be on a clinically stable dose by the investigator prior to study entry Must have a life expectancy of greater than three (3) months Karnofsky Performance Status > 60 Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal.) Exclusion Criteria: Patients with symptomatic CNS metastases or leptomeningeal involvement Patients with known brain metastases, unless these metastases have been treated and/or have been stable for at least six months prior to study start. Subjects with a history of brain metastases must have a head CT with contrast to document either response or progression. Patients with bone metastases as the only site(s) of measurable disease Patients with hepatic artery chemoembolization within the last 6 months (one month if there are other sites of measurable disease) Patients who have been previously treated with radioactive directed therapies Patients who have been previously treated with epothilone Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1 Patients with severe cardiac insufficiency patients taking Coumadin or other warfarin-containing agents with the exception of low dose warfarin (1 mg or less) for the maintenance of in-dwelling lines or ports Patients taking any experimental therapies history of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae Patients with a medical or psychiatric illness that would preclude study or informed consent and/or history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits HIV+ patients Pregnant or lactating females.

Sites / Locations

  • Northwestern University
  • University of Iowa Health Care
  • LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)
  • Weill Medical College of Cornell Univ.
  • Oregon Health Sciences University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EPO906

Arm Description

Outcomes

Primary Outcome Measures

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcome Measures

Time to progression
Overall survival

Full Information

First Posted
December 4, 2002
Last Updated
February 28, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00050349
Brief Title
EPO906 in Carcinoid and Other Neuroendocrine Tumors
Official Title
EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause metastatic carcinoid and other neuroendocrine tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid, Neuroendocrine Tumors
Keywords
cancer, tumor, tumour, neoplasm, carcinoma, carcinoid, neuroendocrine, Islet cell, Gastrinoma, VIPoma, metastatic, intravenous, epothilone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPO906
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
EPO906 epothilone B
Other Intervention Name(s)
patupilone
Primary Outcome Measure Information:
Title
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
every 12 weeks
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
until documented disease progression, death or date of follow up
Title
Overall survival
Time Frame
after treatment, every 3 months (maximum of 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with biopsy-proven metastatic carcinoid tumors or other neuroendocrine tumors (Islet cell, Gastrinomas and VIPomas) with at least one measurable lesion (other than bone) that has either not been previously irradiated or if previously irradiated has demonstrated progression since the radiation therapy The patient has no major impairment of renal or hepatic function, as defined by the following laboratory parameters: total bilirubin <1.5 X ULN; AST, ALT<2.5X ULN (<5 X ULN if liver metastases are present) Patients on Sandostatin Lar (long acting somatostatin analogue) must be on a stable dose for 30 days prior to study entry and short acting somatostatin analogues must be judged to be on a clinically stable dose by the investigator prior to study entry Must have a life expectancy of greater than three (3) months Karnofsky Performance Status > 60 Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal.) Exclusion Criteria: Patients with symptomatic CNS metastases or leptomeningeal involvement Patients with known brain metastases, unless these metastases have been treated and/or have been stable for at least six months prior to study start. Subjects with a history of brain metastases must have a head CT with contrast to document either response or progression. Patients with bone metastases as the only site(s) of measurable disease Patients with hepatic artery chemoembolization within the last 6 months (one month if there are other sites of measurable disease) Patients who have been previously treated with radioactive directed therapies Patients who have been previously treated with epothilone Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1 Patients with severe cardiac insufficiency patients taking Coumadin or other warfarin-containing agents with the exception of low dose warfarin (1 mg or less) for the maintenance of in-dwelling lines or ports Patients taking any experimental therapies history of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae Patients with a medical or psychiatric illness that would preclude study or informed consent and/or history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits HIV+ patients Pregnant or lactating females.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa Health Care
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1091
Country
United States
Facility Name
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Weill Medical College of Cornell Univ.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

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EPO906 in Carcinoid and Other Neuroendocrine Tumors

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