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Pilot study of huachansu in patients with hepatocellular carcinoma, nonsmall-cell lung cancer, or pancreatic cancer

  1. Zhiqiang Meng MD, PhD1,
  2. Peiying Yang PhD2,
  3. Yehua Shen MD1,
  4. Wenying Bei RN1,
  5. Ying Zhang RN1,
  6. Yongqian Ge MD1,
  7. Robert A. Newman PhD3,†,
  8. Lorenzo Cohen PhD2,4,*,
  9. Luming Liu MD, PhD1,§,*,
  10. Bob Thornton MPH2,‡,
  11. David Z. Chang PhD5,
  12. Zongxing Liao MD6,
  13. Razelle Kurzrock MD7

Article first published online: 21 AUG 2009

DOI: 10.1002/cncr.24602

Issue

Cancer

Cancer

Volume 115, Issue 22, pages 5309–5318, 15 November 2009

Additional Information

How to Cite

Meng, Z., Yang, P., Shen, Y., Bei, W., Zhang, Y., Ge, Y., Newman, R. A., Cohen, L., Liu, L., Thornton, B., Chang, D. Z., Liao, Z. and Kurzrock, R. (2009), Pilot study of huachansu in patients with hepatocellular carcinoma, nonsmall-cell lung cancer, or pancreatic cancer. Cancer, 115: 5309–5318. doi: 10.1002/cncr.24602

Author Information

  1. 1

    International Center of Integrative Oncology, Fudan University Cancer Hospital, Shanghai, China

  2. 2

    The Integrative Medicine Program, Department of General Oncology, The University of Texas M. D. Anderson Cancer, Houston, Texas

  3. 3

    Department of Experimental Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

  4. 4

    Department of Behavioral Science, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

  5. 5

    Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

  6. 6

    Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

  7. 7

    Department of Investigational Cancer Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

  1. †

    New Chapter Inc, Brattleboro, Vermont

  2. ‡

    Merck & Co, Inc., Whitehouse Station, New Jersey

  1. §

    Fax: (011) 862164437657

*Department of Behavioral Science, Unit 145, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030

  1. §

    Fax: (011) 862164437657

Publication History

  1. Issue published online: 3 NOV 2009
  2. Article first published online: 21 AUG 2009
  3. Manuscript Accepted: 23 FEB 2009
  4. Manuscript Revised: 20 FEB 2009
  5. Manuscript Received: 3 SEP 2008

Funded by

  • National Cancer Institute. Grant Numbers: CA108084, CA12153031

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Keywords:

  • pancreatic cancer;
  • hepatocellular cancer;
  • nonsmall cell lung cancer;
  • phase 1;
  • traditional Chinese medicine

Abstract

BACKGROUND:

Huachansu, a Chinese medicine that comes from dried toad venom from the skin glands of Bufo gargarizans or B. melanostictus, has been used in the treatment of various cancers in China. The authors conducted a pilot study, using a phase 1 trial design, of huachansu in patients with advanced cancer.

METHODS:

Huachansu was administered intravenously for 14 days followed by 7 days off (1 cycle). Without significant adverse events or progressive disease, treatment continued beyond 2 cycles. The dose of huachansu was escalated as follows with 3 patients per cohort: 10 (level 1), 20 (level 2), 40 (level 3), 60 (level 4), and 90 (level 5) mL/m2.

RESULTS:

Fifteen patients (hepatocellular cancer, n = 11; nonsmall cell lung cancer, n = 2; pancreatic cancer, n = 2) were enrolled in the trial, and no dose-limiting toxicities (DLTs) were found. Eleven patients had no drug-related toxicity greater than grade 1. Six (40%) had stable disease (median duration, 6.0 months; range, 3.5-11.1 months). One of these patients (with hepatocellular cancer) had 20% regression (duration, 11 months) (dose level 1). Quality of life improved for patients with stable disease. Plasma bufalin concentration reached maximal levels at the end of the 2-hour infusion and was proportional to the amount of drug being administered (0.81-3.38 ng/mL).

CONCLUSIONS:

No DLT was observed with the use of huachansu at doses up to 8× higher than typically used in China. Six patients had prolonged stable disease or minor tumor shrinkage. Cancer 2009. © 2009 American Cancer Society.

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