EPO906 in Carcinoid and Other Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:

EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050349
• Other study ID #: CEPO906A2212
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2002
• Last updated: February 28, 2017
• Start date: July 2002
• Est. completion date: April 2007

Study information

• Verified date: March 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoid
• Carcinoid Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• EPO906 epothilone B

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Iowa Health Care	Iowa City	Iowa
United States	LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)	New Orleans	Louisiana
United States	Weill Medical College of Cornell Univ.	New York	New York
United States	Oregon Health Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)		every 12 weeks
Secondary	Time to progression		until documented disease progression, death or date of follow up
Secondary	Overall survival		after treatment, every 3 months (maximum of 12 months)

External Links

•   Results for CEPO906A2212 from the Novartis Clinical Trials website