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An investigational new drug treatment program for patients with gemcitabine : Results for over 3000 patients with pancreatic carcinoma by Anna Maria Storniolo; Nathan H. Enas; Cheryl A. Brown; Maurizio Voi; Mace L. Rothenberg; Richard Schilsky is a scholarly article available to read on EtoBox.

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BACKGROUND. An Investigational New Drug (IND) treatment program allows patients access to a drug that has shown activity against a serious or life-threatening disease prior to full Food and Drug Administration (FDA) review and approval. This treatment IND program, in which patients with locally advanced or metastatic pancreatic carcinoma were treated with gemcitabine, began in 1995. ## METHODS. Eligibility criteria were Յ1 prior chemotherapy regimen; a Karnofsky performance status (KPS) of Ն50; and adequate bone marrow, liver, and renal function. Gemcitabine was given at a dose of 1000 mg/m 2 weekly ϫ 7 followed by a week of rest, then weekly ϫ 3 every 4 weeks thereafter. In this program, diseaserelated symptom improvement (DRSI) was defined retrospectively as 1) improvement in pain (on a 7-point scale) and/or analgesic class (e.g., morphine improving to codeine) and/or KPS (Ն20 points), or 2) stability of these three parameters with a 7% increase in weight from baseline. ## Results . A total of 3023 patients enrolled. At baseline, 80% of them had Stage IV disease, and 84% had a baseline KPS Ն 70. The median age was 65 years, and 56% of the patients were male. The cumulative DRSI r

Author

Anna Maria Storniolo; Nathan H. Enas; Cheryl A. Brown; Maurizio Voi; Mace L. Rothenberg; Richard Schilsky

Publisher

John Wiley and Sons; Wiley (John Wiley & Sons); John Wiley & Sons Inc.; Wiley (ISSN 0008-543X)

Published

1999

Language

EN