EPO906 in Carcinoid and Other Neuroendocrine Tumors

NCT00050349 | Completed Phase 2

• 1 other identifier: CEPO906A2212
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 5

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.

Conditions

Carcinoid; Neuroendocrine Tumors

Keywords

cancer; tumor; tumour; neoplasm; carcinoma; carcinoid; neuroendocrine; Islet cell; Gastrinoma; VIPoma; metastatic; intravenous; epothilone

Outcome Measures

Primary Outcomes (1)

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

  every 12 weeks

Secondary Outcomes (2)

• Time to progression

  until documented disease progression, death or date of follow up

• Overall survival

  after treatment, every 3 months (maximum of 12 months)

Study Arms (1)

EPO906

EXPERIMENTAL

Drug: EPO906 epothilone B

Interventions

EPO906 epothilone B DRUG

Also known as: patupilone

EPO906

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa Health Care

Iowa City, Iowa, 52242-1091, United States

Location

LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)

New Orleans, Louisiana, 70115, United States

Location

Weill Medical College of Cornell Univ.

New York, New York, 10021, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Carcinoid Tumor; Neuroendocrine Tumors; Neoplasms; Carcinoma; Gastrinoma; Vipoma; Neoplasm Metastasis

Interventions

epothilone B

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Carcinoma, Islet Cell; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Neuroendocrine; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2002
• First Posted: December 5, 2002
• Study Start: July 1, 2002
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: March 1, 2017

Record last verified: 2013-03

Locations

US (5)