None listed
Conditions
Brief summary
This trial builds on a phase I (ACTRN12610000684022) study of toxicity in investigating a new combination treatment of gefitinib and methotrexate for the treatment of ectopic pregnancy. This study will recruit 40 women diagnosed with a haemodynamically stable ectopic pregnancy with any pre-treatment serum hCG level. As methotrexate is clinically indicated for women with ectopic pregnancies with a starting serum beta hCG of less then 3000IU/L, this study will seek to show that combination treatment with gefitinib is more efficacious and enables more women to avoid surgery for managment of their ectopic pregnancy.
Interventions
50mg/m2 of intramuscular methotrexate on day 1 of treatment PLUS 250mg of oral gefitinib daily for seven days (day 1 to day 7 of treatment) PLUS/MINUS additional doses of 50mg/m2 IM methotrexate on day 7 if serum hCG has not fallen >15% between days 4 and 7 PLUS/MINUS additional dose of 50mg/m2 IM methotrexate on day 14 if serum hCG has not fallen >15% between days 11 and 14
Sponsors
Associate Professor Stephen Tong
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Women diagnosed with a haemodynamically stable ectopic pregnancy with any level of pre-treatment serum hCG.
Exclusion criteria
Haemodynamic instability, women of Japanese ethnicity, chronic and/or severe history of lung disease including lung cancer history, history of severe gastrointestinal and dermatological conditions, hepatic or renal dysfunction on screening blood tests, allergy to gefitinib/methotrexate.
Outcome results
None listed