Faculty Collaboration Database

Phase 1 clinical trials in 83 patients with pancreatic cancer: The M. D. Anderson Cancer Center experience. Cancer 2011 Jan 01;117(1):77-85

Date

08/26/2010

Pubmed ID

20737567

Pubmed Central ID

PMC3410640

DOI

10.1002/cncr.25346

Scopus ID

2-s2.0-78650711793 (requires institutional sign-in at Scopus site)   7 Citations

Abstract

BACKGROUND: 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 1 clinical trials at a single institution.

METHODS: The authors 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 years). 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 1 clinic was 5.0 months (95% confidence interval [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 was 1.5 months (95% CI, 1.3-1.8). Independent factors associated with lower rates of PR/SD were liver metastases (P = .001) and performance status >0 (P = .01). Independent factors associated with shorter survival were liver metastases (P = .007), low calcium level (P = .015), and elevated CEA level (>6 ng/mL) (P = .005).

CONCLUSIONS: Our results suggest that phase 1 clinical trials offer a reasonable therapeutic approach for patients with advanced pancreatic cancer.

Author List

Vaklavas C, Tsimberidou AM, Wen S, Hong D, Wheler J, Ng CS, Naing A, Uehara C, Wolff RA, Kurzrock R

Author

Razelle Kurzrock MD Center Associate Director, Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Aged, 80 and over
Antineoplastic Agents
Antineoplastic Combined Chemotherapy Protocols
Disease Progression
Female
Humans
Male
Middle Aged
Neoplasm Metastasis
Pancreatic Neoplasms
Treatment Outcome