A phase I trial of cisplatin in hypertonic saline and escalating doses of 5‐fluorouracil by continuous intravenous infusion in patients with advanced malignancies Academic Article Article uri icon


MeSH Major

  • Mycosis Fungoides
  • Sezary Syndrome


  • Thirty-four patients with incurable solid tumors were treated in a Phase I trial with a fixed dose of high-dose cisplatin (CDDP) administered in hypertonic saline and escalating doses of infusional 5-fluorouracil (5-FU). Five treatment levels of 5-FU, ranging from 500 to 900 mg/m2/day for 5 days, were studied. Leukopenia, thrombocytopenia, and oral mucositis were the dose-limiting toxicities encountered. Nephrotoxicity was minimal. Ototoxicity and peripheral neuropathies were rare and mild in this patient group, but most patients received only a small number of treatment cycles. Diarrhea was not dose-limiting. Two complete responses (one non-small cell lung cancer and one sweat gland carcinoma) were observed. No other major responses were noted. With the dose of CDDP set at 35 mg/m2/day for 5 consecutive days, the maximum tolerated dose (MTD) of a concurrent 5-day 5-FU infusion was found to be 900 mg/m2/day. The recommended dosages for Phase II trials are 35 mg/m2/day CDDP and 800 mg/m2/day 5-FU for 5 consecutive days. Cancers of the lung, breast, gastrointestinal tract, and genitourinary tract would be reasonable targets for Phase II studies.

publication date

  • January 1990



  • Academic Article


Digital Object Identifier (DOI)

  • 10.1002/1097-0142(19901015)66:8<1688::AID-CNCR2820660806>3.0.CO;2-K

PubMed ID

  • 2208023

Additional Document Info

start page

  • 1688

end page

  • 91


  • 66


  • 8