TerminatedPhase 1ACTRN12611000104954

Combination Gefitinib and Methotrexate for the Treatment of Persistent Gestational Trophoblastic Disease: A Phase I Clinical Trial

Sponsor

Miss Orla McNally, Director Gynaecological Oncology & Dysplasia

Enrollment

12 participants

Start Date

Nov 25, 2011

Study Type

Interventional

Conditions

Persistent Gestational Trophoblastic Disease

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

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two medications (gefitinib and methotrexate) for women aged 18-45 with persistent gestational trophoblastic disease, a rare condition that can occur after pregnancy. The goal is to find a new treatment option for this condition.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

VIC, Australia

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ACTRN12611000104954