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Study Objective: To determine efficacy and tolerability of granulocyte-macrophage colony-stimulating factor (GM-CSF) in chemotherapy-naive patients with ovarian carcinoma treated with chemotherapy., Setting: University Hospital Groningen., Material and Methods: Prospective double-blind randomised placebo-controlled study in 15 patients with stage III-IV ovarian carcinoma treated with six cycles of carboplatin (300 mg/m2) and cyclophosphamide (750 mg/m2) i.v. bolus day 1 every four weeks. Mammalian-derived GM-CSF or placebo was administered s.c. on an outpatient basis on days 6-12 at three dose steps (1.5, 3 and 6 micrograms/kg/day). At each dose step three patients received GM-CSF and two placebo., Results: GM-CSF raised the mean leukocyte count (days 7, 10 and 15), neutrophil count (days 7 and 10), eosinophil count (days 10 and 15) and monocyte count (day 15) at all three dose steps compared with the control group. The mean platelet count was raised at the 3 and 6 micrograms GM-CSF doses on days 15 and 22. Neutrophil counts of less than 0.5 x 10(9)/l occurred in 20/22 cycles in the control group and in 5/17 cycles at the 6 micrograms/kg/day GM-CSF dose level (p less than 0.0005). Local infiltrates at GM-CSF injection site were observed in eight patients in the GM-CSF group, leading to premature removal from the study of two patients. Chemotherapy dose reduction or postponement due to myelotoxicity occurred in 9/28 cycles in the placebo group versus 5/44 cycles in the GM-CSF group (N.S.)., Conclusion: A dose of 3 and 6 micrograms/kg/day GM-CSF reduces the severity of neutropenia and thrombocytopenia after carboplatin-cyclophosphamide chemotherapy, which may lead to more effective chemotherapy for ovarian cancer in the future.