Treatment of ectopic pregnancies of participants with vinorelbine tablets.

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Ectopic pregnancies are pregnancies that occur outside of the womb, with the vast majority located in the Fallopian tube (the tube which carries a fertilised egg to the womb). They are potentially life threatening as they can erode maternal blood vessels and cause fatal internal bleeding. They are relatively common, representing around 2% of pregnancies. If an ectopic pregnancy is identified early and is small in size, a drug called methotrexate can be administered via injection. However, only a small number of ectopic pregnancies (~25%) are identified early enough to be suitable for this medication. Additionally, methotrexate is unsuccessful in treating ectopic pregnancies in up to 30% of cases. This means that the majority of ectopic pregnancies are ultimately removed surgically. This exposes many affected women to both surgical and anaesthetic risks; is complex (requiring doctors with specialist surgical skills); and can involve the removal of the woman’s Fallopian tube. As fertility preservation is an important concern in this area of medicine, the development of a new medical therapy with a higher success rate than methotrexate would be a major advance in the clinical care of women who have ectopic pregnancies. Excitingly, we have discovered in pre-clinical laboratory studies that vinorelbine, an orally available chemotherapeutic medication, may be appropriate for use as an alternative to methotrexate in the medical treatment of ectopic pregnancies. Specifically, we have found in our laboratory studies that vinorelbine is 1,000 to 10,000 times more effective than methotrexate at killing placental cells, is more effective than methotrexate in an animal model ectopic pregnancy, does not cause cell death of donated human Fallopian tubes and does not impact upon subsequent breeding in mice (after a four week washout period). Together, these findings indicate that vinorelbine may not impede future fertility, and that may be an efficacious treatment for ectopic pregnancy. Given these promising pre-clinical results, we hope to progress this concept and eventually translate these laboratory findings into clinical care. We propose to begin this process with a proof-of-concept, early phase clinical trial. We will recruit 20 women with stable ectopic pregnancies and treat the participants with two doses of 60mg/m² of oral vinorelbine, spaced one week apart. We will assess the safety, toxicity and tolerability of vinorelbine therapy in these women, as well as monitoring the effectiveness of vinorelbine in killing placental cells and resolving ectopic pregnancies. If successful, we will gain sufficient evidence to progress our investigations of vinorelbine as a treatment for ectopic pregnancies to a large-scale, randomized clinical trial. We hope that it may form the basis for an efficient and safe future medical treatment option for this group of women who do not wish to undergo surgery or have their tube removed.

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