The safety and maximum tolerated dose (MTD) of erlotinib with docetaxel/carboplatin were assessed in patients with ovarian cancer.
Chemonaive patients received intravenous docetaxel (75 mg m 2
) and carboplatin (area under the curve 5) on day 1 of a 3-week cycle, and oral erlotinib at 50 (cohort 1), 100 (cohort 2a) or 75 mg day 1 (cohort 2b) for up to six cycles. Dose-limiting toxicities
were determined in cycle 1. Forty-five patients (median age 59 years) received treatment. Dose-limiting toxicities occurred in 1/5/5
patients (cohorts 1/2a/2b). The MTD of erlotinib in this regimen was determined to be 75 mg day 1 (cohort 2b; the erlotinib dose
was escalated to 100 mg day 1 in 11 out of 19 patients from cycle 2 onwards). Neutropaenia was the predominant grade 3/4
haematological toxicity (85/100/95% respectively). Common non-haematological toxicities were diarrhoea, fatigue, nausea and rash.
There were five complete and seven partial responses in 23 evaluable patients (52% response rate). Docetaxel/carboplatin had no measurable effect on erlotinib pharmacokinetics. In subsequent single-agent maintenance, erlotinib was given at 100–150 mg day 1, with manageable toxicity, until tumour progression. Further investigation of erlotinib in epithelial ovarian carcinoma may be warranted, particularly as maintenance therapy.