Phase 1 clinical trials in 83 patients with pancreatic cancer

The M. D. Anderson Cancer Center experience

Authors

  • Christos Vaklavas MD,

    1. Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, The University of Texas M. D. Anderson Cancer Center
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    • The first and second authors contributed equally to this article.

  • Apostolia-Maria Tsimberidou MD, PhD,

    Corresponding author
    1. Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, The University of Texas M. D. Anderson Cancer Center
    • Department of Investigational Cancer Therapeutics, Unit 455, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030
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    • The first and second authors contributed equally to this article.

    • Fax: (713) 794-3249

  • Sijin Wen PhD,

    1. Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center
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  • David Hong MD,

    1. Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, The University of Texas M. D. Anderson Cancer Center
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  • Jennifer Wheler MD,

    1. Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, The University of Texas M. D. Anderson Cancer Center
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  • Chaan S. Ng MD,

    1. Department of Diagnostic Radiology, The University of Texas M. D. Anderson Cancer Center
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  • Aung Naing MD,

    1. Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, The University of Texas M. D. Anderson Cancer Center
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  • Cynthia Uehara,

    1. Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, The University of Texas M. D. Anderson Cancer Center
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  • Robert A. Wolff MD,

    1. Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center
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  • Razelle Kurzrock MD

    1. Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, The University of Texas M. D. Anderson Cancer Center
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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. Cancer 2011. © 2010 American Cancer Society.

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