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EPO906 in Carcinoid and Other Neuroendocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00050349
Recruitment Status : Completed
First Posted : December 5, 2002
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Carcinoid Neuroendocrine Tumors Drug: EPO906 epothilone B Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors
Study Start Date : July 2002
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Arm Intervention/treatment
Experimental: EPO906 Drug: EPO906 epothilone B
Other Name: patupilone

Primary Outcome Measures :
  1. 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 Measures :
  1. Time to progression [ Time Frame: until documented disease progression, death or date of follow up ]
  2. Overall survival [ Time Frame: after treatment, every 3 months (maximum of 12 months) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00050349

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Health Care
Iowa City, Iowa, United States, 52242-1091
United States, Louisiana
New Orleans, Louisiana, United States, 70115
United States, New York
Weill Medical College of Cornell Univ.
New York, New York, United States, 10021
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00050349    
Other Study ID Numbers: CEPO906A2212
First Posted: December 5, 2002    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: March 2013
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Islet cell
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents