A phase I trial of MTA and gemcitabine in patients with locally advanced or metastatic cancer

Semin Oncol. 1999 Apr;26(2 Suppl 6):94-8.

Abstract

MTA has demonstrated activity in breast, lung, bladder, and gastrointestinal malignancies in early clinical trials. Gemcitabine is a cytotoxic pyrimidine antimetabolite with broad activity against solid tumors. We have demonstrated sequence-dependent in vitro cytotoxic synergy when gemcitabine exposure preceded MTA exposure in cultured human HCT-8 colon carcinoma cells. A phase I study testing this synergy in patients is in progress. To date, 14 patients with solid tumors have received 42 courses of treatment at a fixed gemcitabine dose of 1,000 mg/m2 on days 1 and 8 and escalating doses of MTA (200, 300, and 400 mg/m2) given 90 minutes after gemcitabine on day 1. Courses are repeated every 3 weeks. The median number of courses received is three (range, one to seven). National Cancer Institute Common Toxicity Criteria grade 4 hematologic toxicity lasting less than 5 days has been leukopenia and neutropenia. Mild to moderate nonhematologic toxicities include arthralgia, nausea, fatigue, fever, rash, and liver function test abnormalities. One partial response occurred in a patient with previously treated metastatic gallbladder cancer. Dose escalation continues.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy
  • Breast Neoplasms / pathology
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Enzyme Inhibitors
  • Female
  • Folic Acid Antagonists
  • Gallbladder Neoplasms / drug therapy
  • Gallbladder Neoplasms / pathology
  • Gemcitabine
  • Glutamates / administration & dosage*
  • Guanine / administration & dosage
  • Guanine / analogs & derivatives*
  • Humans
  • Lung Neoplasms / drug therapy
  • Lung Neoplasms / pathology
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local / drug therapy
  • Neoplasms / drug therapy*
  • Neoplasms, Unknown Primary / drug therapy
  • Pancreatic Neoplasms / drug therapy
  • Pancreatic Neoplasms / pathology
  • Pemetrexed

Substances

  • Enzyme Inhibitors
  • Folic Acid Antagonists
  • Glutamates
  • Pemetrexed
  • Deoxycytidine
  • Guanine
  • Gemcitabine