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

Phase 2
18 Years
Not Enrolling
Carcinoid, Neuroendocrine Tumors

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Trial Information

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

every 12 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

July 2002

Completion Date:

April 2007

Related Keywords:

  • Carcinoid
  • Neuroendocrine Tumors
  • cancer
  • tumor
  • tumour
  • neoplasm
  • carcinoma
  • carcinoid
  • neuroendocrine
  • Islet cell
  • Gastrinoma
  • VIPoma
  • metastatic
  • intravenous
  • epothilone
  • Carcinoid Tumor
  • Neuroendocrine Tumors



Northwestern University Chicago, Illinois  60611
Oregon Health Sciences University Portland, Oregon  
University of Iowa Health Care Iowa City, Iowa  52242
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2) New Orleans, Louisiana  70115
Weill Medical College of Cornell Univ. New York, New York  10021