Skip to main content
SpringerLink
Log in

Evaluation of Gemcitabine in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: A Southwest Oncology Group Phase II Study

  • Published:
Investigational New Drugs Aims and scope Submit manuscript

Abstract

A phase II trial of gemcitabine(Gemzar®), a nucleoside analogue with broadactivity in solid tumors, was performed inpatients with recurrent or metastaticsquamous cell carcinoma of the head andneck. A total of 26 eligible patients wereregistered to receive a dose of1250 mg/m2 weekly for 3 weeks,followed by a 1 week rest. Toxicity wasevaluable in 26 patients. Nausea andvomiting occured in 11 and 6 patients,repectively. Grade 3 or 4 hematologictoxicities were infrequent. Two patientsdeveloped neutropenic infections. Onepatient developed fatal liver failure whichwas thought due to progressive livermetastases or infection 14 days after asingle dose of gemcitabine. There were noobjective treatment responses (95% CI0–13%), with a median survival of 6 monthsin this highly resistant diseasepopulation. Gemcitabine is not consideredactive enough as monotherapy for furtherevaluation in this disease population.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

REFERENCES

  1. Schantz SP, Harrison LB, Forastiere AA: Tumors of the nasal cavity and paranasal sinuses, nasopharynx, oral cavity and oropharynx. De Vita VT, Hellman S, Rosenberg SA. Cancer: Principles and practice of oncology. 5 ed. Philadelphia: Lippincott-Raven, 1997, 741–803

    Google Scholar 

  2. Kish JA, Weaver A, Jacobs J, Cummings G, Al-Sarraf M: Cisplatin and 5-fluorouracil infusion in patients with recurrent and disseminated epidermoid cancer of the head and neck. Cancer 53: 1819–1824, 1984

    Google Scholar 

  3. Forastiere AA, Metch B, Schuller DE, Ensley JF, Hutchins LF, Triozzi P, Kish J, McClure S, Von Feldt E, Williamson SK, Von Hoff DD: Randomized comparison of cisplatin plus fluorouracil and carboplatin plus fluorouracil versus methotrexate in advanced squamous-cell carcinoma of the head and neck: A Southwest Oncology Group study. J Clin Oncol 10: 1245–1251, 1992

    Google Scholar 

  4. Jacobs C, Lyman G, Velez Garcia E, Sridhar KS, Knight W, Hochster H, Goodnough LT, Mortimer JE, Einhorn LH, Schacter L, et al: A phase III randomized study comparing cisplatin and fluorouracil as single agents and in combination for advanced squamous cell carcinoma of the head and neck. J Clin Oncol 10: 257–263, 1992

    Google Scholar 

  5. Schrijvers D, Johnson J, Jiminez U, Gore M, Kosmidis P, Szpirglas H, et al: Phase III trial of modulation of cisplatin/ fluorouracil chemotherapy by interferon alfa-2b in patients with recurrent or metastatic head and neck cancer. Head and Neck Interferon Cooperative Study Group. J Clin Oncol 16: 1054–1059, 1998

    Google Scholar 

  6. Plunkett W, Huang P, Xu YZ, Heinemann V, Grunewald R, Gandhi V: Gemcitabine: metabolism, mechanisms of action, and self-potentiation. Semin Oncol 22: 3–10, 1995

    Google Scholar 

  7. Huang P, Plunkett W: Fludarabine-and gemcitabine-induced apoptosis: incorporation of analogs into DNA is a critical event. Cancer Chemother Pharmacol 36: 181–188, 1995

    Google Scholar 

  8. Hertel LW, Boder GB, Kroin JS, Rinzel SM, Poore GA, Todd GC, Grindey GB: Evaluation of the antitumor activity of gemcitabine (2′,2′-difluoro-2′-deoxycytidine). Cancer Res 50: 4417–4422, 1990

    Google Scholar 

  9. Hanauske AR, Degen D, Marshall MH, Hilsenbeck SG, Grindey GB, Von Hoff DD: Activity of 2′,2′-difluorodeoxycytidine (gemcitabine) against human tumor colony forming units. Anti-Cancer Drugs 3: 143–146, 1992

    Google Scholar 

  10. Gemcitabine HCl (LY188011 HCl): Clinical Investigation Brochure. Indianapolis: Eli Lilly and Co., 1993.

  11. Pollera CF, Ceribelli A, Crecco M, Calabresi F: Weekly gemcitabine in advanced or metastatic solid tumors. A clinical phase I study. Invest New Drugs 12: 111–119, 1994

    Google Scholar 

  12. Niyikiza C, Andersen JS, Tarassoff PG, Rothenberg ML, Seitz DE, Nelson RL, Moore M, Storniolo AM: Prognostic factors in a randomized trial of gemcitabine (GEM) versus 5-FU as first-line therapy in advanced pancreatic cancer and in pancreatic cancer patients failing 5-FU who received gemcitabine as a palliative therapy. Proc Am Soc Clin Oncol 15: 506, 1996

    Google Scholar 

  13. Carmichael J, Possinger K, Phillip P, Beykirch M, Kerr H, Walling J, Harris AL: Advanced breast cancer: a phase II trial with gemcitabine. J Clin Oncol 13: 2731–2736, 1995

    Google Scholar 

  14. Sorensen JB: Gemcitabine in non-small cell lung cancer. Lung Cancer 12 Suppl 1: S173–S175, 1995

    Google Scholar 

  15. Lund B, Hansen OP, Theilade K, Hansen M, Neijt JP: Phase II study of gemcitabine (2′,2′-difluorodeoxycytidine) in previously treated ovarian cancer patients. J Natl Cancer Inst 86: 1530–1533, 1994

    Google Scholar 

  16. Catimel G, Vermorken JB, Clavel M, de Mulder P, Judson I, Sessa C, Piccart M, Bruntsch U, Verweij J, Wanders J, et al: A phase II study of gemcitabine (LY 188011) in patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group. Ann Oncol 5: 543–547, 1994

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, U.S.A.

    Wolfram E. Samlowski

  2. Southwest Oncology Group Statistical Center, Seattle, WA, U.S.A.

    Holly Gundacker

  3. Columbus CCOP, Columbus, OH, U.S.A.

    J. Philip Kuebler

  4. Greenville CCOP, Greenville, SC, U.S.A.

    Jeffrey K. Giguere

  5. Louisiana State University Medical Center, Shreveport, LA, U.S.A.

    Glenn M. Mills

  6. Ohio State University Health Center, Columbus, OH, U.S.A.

    David E. Schuller

  7. Wayne State University Medical Center, Detroit, MI, U.S.A.

    John F. Ensley

Authors
  1. Wolfram E. Samlowski
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Holly Gundacker
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. J. Philip Kuebler
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jeffrey K. Giguere
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Glenn M. Mills
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. David E. Schuller
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. John F. Ensley
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Samlowski, W.E., Gundacker, H., Kuebler, J.P. et al. Evaluation of Gemcitabine in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: A Southwest Oncology Group Phase II Study. Invest New Drugs 19, 311–315 (2001). https://doi.org/10.1023/A:1010657609609

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1023/A:1010657609609

Search

Navigation