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EPO906 in Carcinoid and Other Neuroendocrine Tumors
This study has been suspended.
Study NCT00050349   Information provided by Novartis
First Received: December 4, 2002   Last Updated: September 18, 2009   History of Changes

December 4, 2002
September 18, 2009
July 2002
 
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Response
Complete list of historical versions of study NCT00050349 on ClinicalTrials.gov Archive Site
  • Time to progression
  • Overall survival
Same as current
 
EPO906 in Carcinoid and Other Neuroendocrine Tumors
EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors

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.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Carcinoid
  • Neuroendocrine Tumors
Drug: EPO906 epothilone B
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Suspended
48
March 2004
 

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00050349
 
CEPO906A2212
Novartis
 
Study Chair: Novartis Novartis
Novartis
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP