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Phase I trial of gemcitabine combined with radiation for the treatment of locally advanced pancreatic adenocarcinoma.

Publication ,  Journal Article
Wolff, RA; Evans, DB; Gravel, DM; Lenzi, R; Pisters, PW; Lee, JE; Janjan, NA; Charnsangavej, C; Abbruzzese, JL
Published in: Clin Cancer Res
August 2001

Gemcitabine has modest activity in the treatment of advanced pancreatic cancer and is a potent radiosensitizer. We conducted a Phase I trial to determine the maximum tolerated dose of weekly gemcitabine delivered concurrently with radiation therapy for the treatment of locally advanced adenocarcinoma of the pancreatic head and to assess the treatment-related toxic effects associated with such a regimen. Eighteen patients with pathologically proven, locally advanced adenocarcinoma of the pancreatic head were enrolled in this study. Patients received seven weekly doses of gemcitabine with 3000 cGy of external beam radiation therapy delivered during the first 2 weeks of therapy. Six patients received gemcitabine at 350 mg/m(2)/week, nine at 400 mg/m(2)/week, and three at 500 mg/m(2)/week. Grade 3-4 hematological toxicity was observed in over half the patients treated. Nonhematological toxicities were significant and included fatigue, anorexia, nausea, vomiting, and dehydration. Forty-four % of the patients required admission to the hospital for management of nausea/vomiting and dehydration. The risk of hospitalization appeared to be dose-related; all of the three patients treated at 500 mg/m(2)/week required hospital admission during treatment. Seventeen patients were evaluated for response, and eight patients (47%) had evidence of a local anticancer effect. Four of these eight patients (24%) had a partial response to therapy. The median survival for the entire group was 6 months. The 1-year survival rate for patients with an objective response to therapy was 66%. The clinical responses observed in this group of patients suggest gemcitabine is a clinically relevant radiosensitizer in patients with pancreatic adenocarcinoma. However, the toxic effects are significant, suggesting that until dose and scheduling issues are explored further, concomitant administration of gemcitabine and radiation therapy should still be considered investigational.

Duke Scholars

Published In

Clin Cancer Res

ISSN

1078-0432

Publication Date

August 2001

Volume

7

Issue

8

Start / End Page

2246 / 2253

Location

United States

Related Subject Headings

  • Vomiting
  • Treatment Outcome
  • Pancreatic Neoplasms
  • Oncology & Carcinogenesis
  • Nausea
  • Middle Aged
  • Male
  • Humans
  • Gemcitabine
  • Female
 

Citation

APA
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MLA
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Wolff, R. A., Evans, D. B., Gravel, D. M., Lenzi, R., Pisters, P. W., Lee, J. E., … Abbruzzese, J. L. (2001). Phase I trial of gemcitabine combined with radiation for the treatment of locally advanced pancreatic adenocarcinoma. Clin Cancer Res, 7(8), 2246–2253.
Wolff, R. A., D. B. Evans, D. M. Gravel, R. Lenzi, P. W. Pisters, J. E. Lee, N. A. Janjan, C. Charnsangavej, and J. L. Abbruzzese. “Phase I trial of gemcitabine combined with radiation for the treatment of locally advanced pancreatic adenocarcinoma.Clin Cancer Res 7, no. 8 (August 2001): 2246–53.
Wolff RA, Evans DB, Gravel DM, Lenzi R, Pisters PW, Lee JE, et al. Phase I trial of gemcitabine combined with radiation for the treatment of locally advanced pancreatic adenocarcinoma. Clin Cancer Res. 2001 Aug;7(8):2246–53.
Wolff, R. A., et al. “Phase I trial of gemcitabine combined with radiation for the treatment of locally advanced pancreatic adenocarcinoma.Clin Cancer Res, vol. 7, no. 8, Aug. 2001, pp. 2246–53.
Wolff RA, Evans DB, Gravel DM, Lenzi R, Pisters PW, Lee JE, Janjan NA, Charnsangavej C, Abbruzzese JL. Phase I trial of gemcitabine combined with radiation for the treatment of locally advanced pancreatic adenocarcinoma. Clin Cancer Res. 2001 Aug;7(8):2246–2253.

Published In

Clin Cancer Res

ISSN

1078-0432

Publication Date

August 2001

Volume

7

Issue

8

Start / End Page

2246 / 2253

Location

United States

Related Subject Headings

  • Vomiting
  • Treatment Outcome
  • Pancreatic Neoplasms
  • Oncology & Carcinogenesis
  • Nausea
  • Middle Aged
  • Male
  • Humans
  • Gemcitabine
  • Female