BENITIONSClinical Trial Intelligence

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

Phase 1/2 Active, not recruiting NCT01064648

ConditionEpithelioid Mesothelioma, Pleural Malignant Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatoid Mesothelioma
PhasePhase 1/2
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment117 participants
InterventionsCediranib Maleate, Cisplatin, Laboratory Biomarker Analysis, Pemetrexed Disodium, Placebo Administration
Start dateMar 15, 2010
Completion dateJun 1, 2018
Results postedFeb 5, 2020

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 Participants20 mg

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 20mg7.2 month
Phase II Cisplatin-pemetrexed Placebo5.6 month
p-value0.06
Hazard Ratio (HR)0.71 (95% CI 0.54–0.95)

Open in BENITIONS View on ClinicalTrials.gov

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