Introduction. The outcomes of patients with pancreatic cancer treated on early-phase clinical trials have not been systematically analyzed. The purpose of this study was to report the presenting characteristics and outcomes of patients with locally advanced or metastatic pancreatic cancer treated on phase I clinical trials at a single institution.

Patients and Methods. We reviewed the records of consecutive patients with metastatic pancreatic cancer who were treated in the Phase I Clinical Trials Program at The University of Texas M. D. Anderson Cancer Center from November 2004 to March 2009. Data recorded and analyzed included survival, response, and disease characteristics.

Results. Eighty-three patients were identified. The median age was 62 years (range, 39-81). There were 40 men and 43 women. The most common metastatic sites were liver (54% of patients), lung (51%), lymph nodes (37%), and peritoneum and omentum (24%). The median number of prior therapies was 2 (range, 0-7). Thirty-two (39%) patients had a history of pancreatectomy. Sixty-seven (81%) patients had ≥1 comorbidity. Of 78 patients evaluable for response, 2 (3%) had a partial response (PR), and 10 (13%) had stable disease (SD) for ≥4 months. With a median follow-up for survivors of 3.7 months, the median survival from presentation in the Phase I Clinic was 5.0 months (95% CI, 3.3-6.2). The median overall survival from diagnosis was 22.1 months (95% CI, 17.9-26.5). The median time to treatment failure (TTF) was 1.5 months (95% CI, 1.3-1.8). In multivariate analysis, independent factors associated with lower rates of PR or SD were liver metastases (p = 0.001) and PS greater than 0 (p = 0.01) (Table 3). Independent factors associated with shorter survival were liver metastases (p = 0.007), calcium ≤ 8.4 mg/nL (p = 0.015), and elevated serum levels of CEA (>6 ng/mL; p = 0.005). Independent factors associated with shorter TTF were history of smoking (p = 0.009), liver metastases (p = 0.001), serum bilirubin levels >1 mg/dL (p = 0.007), and >1 prior therapy (p = 0.002).

Conclusions. The median survival in the current study (5 months) compares favorably to the median survival reported with best supportive care (3 months). Our results suggest that phase I clinical trials offer a reasonable therapeutic approach for patients with advanced pancreatic cancer.

Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 101st Annual Meeting of the American Association for Cancer Research; 2010 Apr 17-21; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2010;70(8 Suppl):Abstract nr 2771.