EPO906 in Carcinoid and Other Neuroendocrine Tumors (NCT00050349) | Clinical Trial Compass
CompletedPhase 2
EPO906 in Carcinoid and Other Neuroendocrine Tumors
United States33 participantsStarted 2002-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)