Carcinoid, Neuroendocrine Tumors
Conditions
Keywords
cancer, tumor, tumour, neoplasm, carcinoma, carcinoid, neuroendocrine, Islet cell, Gastrinoma, VIPoma, metastatic, intravenous, epothilone
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.
Interventions
DRUGEPO906 epothilone B
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) | every 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | until documented disease progression, death or date of follow up |
| Overall survival | after treatment, every 3 months (maximum of 12 months) |
Countries
United States
Outcome results
None listed