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Phase II study of thalidomide in patients with metastatic carcinoid and islet cell tumors.
- Source :
-
Cancer Chemotherapy & Pharmacology . Apr2008, Vol. 61 Issue 4, p661-668. 8p. 5 Charts. - Publication Year :
- 2008
-
Abstract
- Carcinoid and islet cell tumors are known to be highly vascular. There is no effective systemic therapy currently available for metastatic disease. We conducted a phase II trial to evaluate the efficacy of the anti-antiangiogenic agent thalidomide in metastatic neuroendocrine tumors. Eighteen patients with measurable, histologically proven metastatic carcinoid neuroendocrine carcinomas (well-differentiated, n = 13; moderately-differentiated, n = 5) were enrolled on this study. The majority of the patients had gastrointestinal primaries (small bowel, 8; pancreas, 5; colon, 1). All but one patient had hepatic metastases, and 12 patients (67%) had carcinoid syndrome. All patients had Eastern Cooperative Oncology Group performance status of zero or one. Eight patients (44%) had received previous hepatic artery chemoembolization and 11 (61%) had undergone surgical resection. Patients were started on oral thalidomide at a daily dose of 200 mg that was escalated to the target dose of 400 mg daily after 2 weeks. Tumor response was assessed at 12-week intervals using RECIST criteria. Planned treatment duration was 24 weeks unless unacceptable toxicity or disease progression was observed. No patient achieved a partial remission or a complete remission. Best response was stable disease (SD) in 11 of 16 response-evaluable patients (69%). Serum pancreastatin results did not correlate with clinical response. Grade 3 toxicities included dizziness with orthostatic hypotension ( n = 5), sensory neuropathy ( n = 2), fatigue ( n = 2), hemorrhagic cystitis ( n = 1), and deep venous thrombosis ( n = 1). Frequent Grade 1–2 toxicities were: fatigue ( n = 13), constipation ( n = 13), dry mouth ( n = 12), somnolence ( n = 12), dizziness/syncope ( n = 10), weight gain ( n = 5), and peripheral neuropathy (n = 5). Thalidomide was fairly well tolerated in patients with metastatic carcinoid/islet cell tumors, but failed to reveal any objective responses. The single stage design of the trial makes it difficult to determine whether observed SD in a subset of patients was attributable to the indolent nature of these tumors, or to beneficial effect of thalidomide. [ABSTRACT FROM AUTHOR]
- Subjects :
- *THALIDOMIDE
*NEUROENDOCRINE tumors
*CARCINOID
*CANCER cells
*MEDICAL research
Subjects
Details
- Language :
- English
- ISSN :
- 03445704
- Volume :
- 61
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- Cancer Chemotherapy & Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 28141449
- Full Text :
- https://doi.org/10.1007/s00280-007-0521-9