Randomized phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant.

@article{Meropol2003RandomizedPI,
  title={Randomized phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant.},
  author={Neal J. Meropol and Robert A. Somer and John C. Gutheil and Robert J. Pelley and Manuel R. Modiano and Eric Keith Rowinsky and MaceL. Rothenberg and Spencer W. Redding and Cuneyt M. Serdar and B. G. Yao and Robert Heard and Lee S. Rosen},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2003},
  volume={21 8},
  pages={
          1452-8
        }
}
PURPOSE To evaluate the safety of recombinant human keratinocyte growth factor (KGF) when administered with fluorouracil (FU) in patients with metastatic colorectal cancer. PATIENTS AND METHODS Patients (N = 81) received KGF by intravenous (IV) bolus on days 1 to 3, followed by FU 425 mg/m2/d IV bolus plus leucovorin 20 mg/m2/d IV on days 4 to 8. KGF dose levels were 1, 10, 20, 40, 60, and 80 microg/kg/d. A randomized, placebo-controlled design was employed (2:1 randomization of KGF to… CONTINUE READING
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