None listed
Conditions
Brief summary
This study will evaluate the safety and efficacy of a chemotherapy treatment regime for the treatment of persistent gestational trophoblastic disease (GTD). Who is it for? You may be eligible to join this study if you are a female aged 18-45 years and have been diagnosed with persistent gestational trophoblastic disease. Trial details Participants in this trial will undergo a standard 14 day methotrexate chemotherapy cycle. In addition they will also take gefitinib tablets. The first 3 participants will take gefitinib on day 1 of chemotherapy only. If this is well tolerated, the next 3 participants will take gefitinib on days 1, 2 and 3 of chemotherapy, and the last 6 participants will take it on days 1-7. Gefitinib is a drug which is already used in the treatment of lung cancer, but has never previously been used to treat GTD. Participants will be accessed regularly during treatment to evaluate the efficacy, safety and tolerability of treatment.
Interventions
Standard 14-day methotrexate chemotherapy cycle (1mg/kg IM methotrexate on days 1, 3, 5, and 7 with alternate day rescue folinic acid 5mg PO on days 2, 4, 6 and 8) with addition of oral 250mg gefitinib in the following dose escalation protocol: the first 3 participants will take gefitinib on day 1 of chemotherapy only. If this is well tolerated, the next 3 participants will take gefitinib on days 1, 2 and 3 of chemotherapy, and the last 6 participants will take it on days 1-7. Concomitant gefiti
Standard 14-day methotrexate chemotherapy cycle (1mg/kg IM methotrexate on days 1, 3, 5, and 7 with alternate day rescue folinic acid 5mg PO on days 2, 4, 6 and 8) with addition of oral 250mg gefitinib in the following dose escalation protocol: the first 3 participants will take gefitinib on day 1 of chemotherapy only. If this is well tolerated, the next 3 participants will take gefitinib on days 1, 2 and 3 of chemotherapy, and the last 6 participants will take it on days 1-7. Concomitant gefitinib treatment will only occur in the first methotrexate chemotherapy cycle.
Sponsors
Miss Orla McNally, Director Gynaecological Oncology & Dysplasia
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Persistent gestational trophoblastic disease diagnosed on tissue histopathology and confirmed by persistence of serum beta human chorionic gonadotropin levels.
Exclusion criteria
Chronic pulmonary disease (excluding mild asthma), severe gastrointesitinal or dermatological disease, Japanese ethinicity, allergy to methotrexate or gefitinib.
Outcome results
None listed