Clinical trial NCT00050349: EPO906 in Carcinoid and Other Neuroendocrine Tumors
Official title: EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoid
Neuroendocrine Tumors
Keywords: cancer
tumor
tumour
neoplasm
carcinoma
carcinoid
neuroendocrine
Islet cell
Gastrinoma
VIPoma
metastatic
intravenous
epothilone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2002-12-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: every 12 weeks
Secondary outcomes:
measure: Time to progression
timeFrame: until documented disease progression, death or date of follow up
measure: Overall survival
timeFrame: after treatment, every 3 months (maximum of 12 months)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
city: New Orleans
country: United States
facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)
state: Louisiana
city: New York
country: United States
facility: Weill Medical College of Cornell Univ.
state: New York
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: