Phase II trial of topotecan in advanced or metastatic adenocarcinoma of the pancreas

A phase II trial of topotecan, an inhibitor of topoisomerase I, was conducted in patients with advanced or metastatic adenocarcinoma of the pancreas to determine the activity and toxicity of topotecan. 35 patients, previously untreated with chemotherapy, received topotecan 1.5 mg/m2/d for five days...

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Bibliographic Details
Published in:Investigational new drugs 1996, Vol.13 (4), p.347
Main Authors: Scher, R M, Kosierowski, R, Lusch, C, Alexander, R, Fox, S, Redei, I, Green, F, Raskay, B, Amfoh, K, Engstrom, P F, O'Dwyer, P J
Format: Article
Language:English
Subjects:
Adenocarcinoma - drug therapy
Adenocarcinoma - secondary
Adult
Aged
Aged, 80 and over
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Camptothecin - adverse effects
Camptothecin - analogs & derivatives
Camptothecin - therapeutic use
Drug Administration Schedule
Female
Humans
Infusions, Intravenous
Male
Middle Aged
Neoplasm Metastasis
Pancreatic Neoplasms - drug therapy
Pancreatic Neoplasms - pathology
Topotecan
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Summary:A phase II trial of topotecan, an inhibitor of topoisomerase I, was conducted in patients with advanced or metastatic adenocarcinoma of the pancreas to determine the activity and toxicity of topotecan. 35 patients, previously untreated with chemotherapy, received topotecan 1.5 mg/m2/d for five days intravenously and repeated every 21 days. Patients were assessed for response after 3 cycles. Those with either clinical response or stable disease received additional cycles of the drug until toxicity developed or disease progression occurred. Among 30 patients evaluable for response there were no complete responses and 3 partial responses (10%) for a total response rate of 10% (95% confidence interval = 0-20.6%). Stable disease for at least eight weeks was seen in 11 patients (36%). Median survival was 19 weeks (95% confidence interval 11 to 26 weeks). Therapy was generally well tolerated, with reversible granulocytopenia being the most common toxicity. Topotecan given on a 5 day, short infusion schedule, demonstrated limited activity in pancreatic carcinoma with minimal toxicity. Further exploration of topotecan in pancreatic carcinoma using different dosing schedules is warranted.
ISSN:0167-6997