GEM for Ectopic Pregnancies II

• Research type

  Research Study

• Full title

  Combination gefitinib and methotrexate to treat ectopic pregnancies II

• IRAS ID

  78193

• Sponsor organisation

  Monash University

• Eudract number

  2001-001747-69

• Research summary

  Ectopic pregnancies are pregnancies that implant outside the uterus and account for approximately 1-2% of all pregnancies. Ectopic pregnancies are still one of the leading causes of maternal death in the first trimester. We currently treat ectopic pregnancies in three ways, conservatively (monitoring until the pregnancy naturally miscarries), surgically (where the pregnancy and often the Fallopian tube are removed) or medically (with an injection of a drug called methotrexate). Successful medical management means the women will avoid surgery and its potential risks. There are significant limitations to medical treatment with methotrexate as it is a chemotherapy drug which targets all dividing cells and has a substantial number of side-effects. Its efficacy has been shown to decrease with increasing ectopic size. Gefitinib is a drug used in the treatment of non-small cell lung cancer and specifically targets EGFR proyein which is found in ectopic pregnancies. We have found in laboratory tests that ectopic pregnancies are more sensitive to treatment with combined methotrexate and gefitinib. We have run a toxicity study (GEM I) and have found this combination to be well tolerated in women. The aim of this study (GEM II) is to determine the efficacy of combination gefitinib and methotrexate in women diagnosed with an unruptured ectopic pregnancy or a pregnancy of unknown location in 50 women over 18 months. We will recruit women and follow them up until cure (defined by serum pregnancy hormone levels [hCG] <5) and will contact them at 3, 6, 12 and 24 months following treatment.

• REC name

  Scotland A REC

• REC reference

  11/AL/0350

• Date of REC Opinion

  2 Aug 2011

• REC opinion

  Further Information Favourable Opinion