Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
Phase 1/2
Active, not recruiting
NCT01064648
| Condition | Epithelioid Mesothelioma, Pleural Malignant Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatoid Mesothelioma |
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| Phase | Phase 1/2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 117 participants |
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| Interventions | Cediranib Maleate, Cisplatin, Laboratory Biomarker Analysis, Pemetrexed Disodium, Placebo Administration |
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| Start date | Mar 15, 2010 |
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| Completion date | Jun 1, 2018 |
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| Results posted | Feb 5, 2020 |
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Summary
This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and to see how well it works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy, pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed disodium and cisplatin together with cediranib maleate may kill more tumor cells.
Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I)
Weekly during first cycle (1cycle = 21 days). Then will be reported every cycle while patient is on treatment. · mg
| All Phase I Participants | 20 mg |
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Progression-free Survival (Phase II)
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever came first, assessed up to 5 years.Disease assessment will be repeated every 6 weeks until disease progression. · month
| Phase II Cisplatin-pemetrexed Cediranib 20mg | 7.2 month |
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| Phase II Cisplatin-pemetrexed Placebo | 5.6 month |
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| p-value | 0.06 |
| Hazard Ratio (HR) | 0.71 (95% CI 0.54–0.95) |
Open in BENITIONS
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