A phase II trial of perifosine in locally advanced, unresectable, or metastatic pancreatic adenocarcinoma.
Am J Clin Oncol
; 30(1): 26-31, 2007 Feb.
Article
en En
| MEDLINE
| ID: mdl-17278891
ABSTRACT
BACKGROUND:
Perifosine, a heterocyclic alkylphosphocholine signal transduction inhibitor, has activity against multiple cell types in vitro. This is a phase II study to determine activity and toxicity of perifosine in pancreatic adenocarcinoma. PATIENTS ANDMETHODS:
Previously untreated patients with locally advanced, unresectable, or metastatic pancreatic adenocarcinoma, performance status Eastern Cooperative Oncology Group 0 or 1, were enrolled. An oral loading dose of 900 mg was followed by 100 mg per day until progression or unacceptable toxicity. Response criteria in solid tumors (RECIST) methodology and a 2-stage design were used. Suspension could occur for inadequate response in the first cohort or for more than 25% grade 3 or greater toxicity.RESULTS:
Ten patients were enrolled. Six received 1 month and 4 received 2 months of treatment. Four discontinued therapy as a result of progression and 2 because of clinical deterioration. Three died during treatment. One patient had stable disease but discontinued therapy as a result of unacceptable adverse events (95% confidence interval 0.3-45%). There were no objective responses and all patients died of progressive disease. Median overall and progression-free survival was 1.85 months (95% confidence interval 0.9-2.7) and 1.5 months (95% confidence interval 0.9-1.9) respectively.CONCLUSION:
The study was suspended and subsequently terminated as a result of unacceptable adverse events during the first stage. Perifosine does not appear to be worthy of further study in this group of patients.
Buscar en Google
Base de datos:
MEDLINE
Asunto principal:
Neoplasias Pancreáticas
/
Fosforilcolina
/
Adenocarcinoma
Límite:
Aged
/
Child
/
Female
/
Humans
/
Middle aged
Idioma:
En
Revista:
Am J Clin Oncol
Año:
2007
Tipo del documento:
Article
País de afiliación:
Estados Unidos