Combination Gefitinib and Methotrexate for the Treatment of Persistent Gestational Trophoblastic Disease: A Phase I Clinical Trial
Miss Orla McNally, Director Gynaecological Oncology & Dysplasia
12 participants
Nov 25, 2011
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- Persistent gestational trophoblastic disease diagnosed on tissue histopathology and confirmed by persistence of serum beta human chorionic gonadotropin levels.
Exclusion Criteria1
- Chronic pulmonary disease (excluding mild asthma), severe gastrointesitinal or dermatological disease, Japanese ethinicity, allergy to methotrexate or gefitinib.
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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 gefitinib treatment will only occur in the first methotrexate chemotherapy cycle.
Locations(1)
View Full Details on ANZCTR
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ACTRN12611000104954