A phase II trial of imatinib mesylate in patients with metastatic pancreatic cancer.
OBJECTIVE
The aim of the study was to assess the clinical efficacy and toxicity of single-agent imatinib mesylate in patients with advanced, unresectable metastatic pancreatic cancer.


METHODS
Previously treated or untreated patients with histologically proven, unresectable pancreatic adenocarcinoma with adequate organ and bone marrow function were enrolled. Patients received imatinib 400 mg orally twice a day for a 28-day cycle. Response was evaluated every 4 weeks by imaging scans. Response was defined as lack of tumor progression at 3 months.


RESULTS
Eleven patients were enrolled, and 9 were evaluable for response. Best response was stable disease in 3 patients after 2 cycles of therapy. All of them subsequently progressed. No patients remained on treatment for 3 months or longer, which was the response end point. Median time to tumor progression was 47 days (range, 19-76 days) and median overall survival was 118 days (range, 40-221 days). The first 3 patients received imatinib 400 mg orally twice a day. Due to unexpected grades 2 and 3 toxicities, the dose was reduced to 600 mg daily which was well tolerated. Most common adverse events included grades 1 to 2 edema, liver enzyme elevations, nausea, and rash.


CONCLUSIONS
Single-agent imatinib does not have a significant activity in pancreatic cancer.
Gharibo
Mecide
M
The Cancer Institute of New Jersey, New Brunswick, NJ 08903, USA. gharibmm@umdnj.edu
Patrick-Miller
Linda
L
Zheng
Ling
L
Guensch
Lisa
L
Juvidian
Parisa
P
Poplin
Elizabeth
E
D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use* / Q000633:toxicity; D001549:Benzamides; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018579:Patient Selection; D010879:Piperazines / Q000627:therapeutic use* / Q000633:toxicity; D011743:Pyrimidines / Q000627:therapeutic use* / Q000633:toxicity; D013997:Time Factors
D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate