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Phase II study of recombinant human endostatin in patients with advanced neuroendocrine tumors.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2006 Aug 01; Vol. 24 (22), pp. 3555-61. - Publication Year :
- 2006
-
Abstract
- Purpose: Endostatin is a 20-kd proteolytic fragment of collagen XVIII that, in preclinical studies, has been shown to have antiangiogenic and antitumor activity. Both preclinical and human phase I studies of recombinant human endostatin (rhEndostatin) suggested activity in neuroendocrine tumors, which are known to be hypervascular. We therefore performed a multicenter phase II study of rhEndostatin in patients with carcinoid or pancreatic neuroendocrine tumors.<br />Patients and Methods: Forty-two patients with advanced pancreatic endocrine tumors or carcinoid tumors were treated with rhEndostatin administered as a bid subcutaneous injection at a starting dose of 60 mg/m2/d. Steady-state trough levels were obtained after 6 weeks of therapy; patients who did not achieve a target therapeutic level of 300 ng/mL underwent dose escalation to 90 mg/m2/d. Patients were observed for evidence of toxicity, response, and survival.<br />Results: rhEndostatin was associated with minimal toxicity. However, among 40 patients assessable for radiologic response, none experienced partial response to therapy, as defined by WHO criteria. The median steady-state trough level achieved after dose escalation was 331 ng/mL, within the postulated therapeutic range.<br />Conclusion: Treatment with rhEndostatin did not result in significant tumor regression in patients with advanced neuroendocrine tumors.
- Subjects :
- Adult
Aged
Aged, 80 and over
Angiogenesis Inhibitors administration & dosage
Angiogenesis Inhibitors adverse effects
Angiogenesis Inhibitors blood
Antineoplastic Agents administration & dosage
Antineoplastic Agents adverse effects
Antineoplastic Agents blood
Carcinoma, Neuroendocrine blood
Carcinoma, Neuroendocrine pathology
Disease-Free Survival
Endostatins administration & dosage
Endostatins adverse effects
Endostatins blood
Female
Humans
Injections, Subcutaneous
Male
Middle Aged
Recombinant Proteins therapeutic use
Self Administration
Survival Analysis
Treatment Outcome
Angiogenesis Inhibitors therapeutic use
Antineoplastic Agents therapeutic use
Carcinoma, Neuroendocrine drug therapy
Endostatins therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 24
- Issue :
- 22
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 16877721
- Full Text :
- https://doi.org/10.1200/JCO.2006.05.6762