A PHASE I II TRIAL OF RECOMBINANT HUMAN GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR IN THE INTENSIFICATION OF CISPLATIN AND CYCLOPHOSPHAMIDE CHEMOTHERAPY FOR ADVANCED OVARIAN-CANCER/

A pilot study was undertaken in eight patients to assess the feasibili ty of recombinant human granulocyte-macrophage colony-stimulating fact or (rH GM-CSF) support to intensify standard chemotherapy for advanced ovarian cancer using a shortened 15 day treatment interval. Only four patients completed the course of six cycles of cisplatin 75 mg m(-2) and cyclophosphamide 750 mg m(-2) with rH GM-CSF, 3-5 mu g kg(-1) day( -1), days 3-14, but one of these suffered a toxic death on study. Anot her died of disease progression. There were two episodes of life-threa tening infection (WHO grade 4), and three patients were withdrawn beca use of various rH GM-CSF-related problems. Although potentially afford ing some patients the hypothetical benefits of dose intensification, a s well as the possible attraction of a shorter duration of chemotherap y, this regimen is not without problems.