Study on Pemetrexed and Cisplatin with or without Cediranib for Treating Malignant Pleural Mesothelioma

Program Overview

The purpose of this study is to find out if adding cediranib to the chemotherapy drugs pemetrexed and cisplatin can help treat malignant pleural mesothelioma more effectively. Cediranib may help stop tumor growth by blocking certain enzymes and blood flow to the tumor. The study will also determine the best dose of cediranib and evaluate its side effects.

Description

This study is divided into two phases. In Phase I, researchers will determine the safest dose of cediranib when combined with pemetrexed and cisplatin. In Phase II, they will compare the effectiveness of the combination treatment to the standard chemotherapy alone.

In Phase I, patients receive pemetrexed and cisplatin through an IV on the first day of each 21-day cycle, along with daily oral doses of cediranib for up to six cycles, unless the disease progresses or side effects become unacceptable. After six cycles, patients may continue taking cediranib alone if it is still effective and well-tolerated.

In Phase II, patients are randomly assigned to one of two groups. One group receives the same treatment as in Phase I, while the other group receives pemetrexed and cisplatin with a placebo instead of cediranib. The study will compare how long patients live without the disease getting worse and overall survival between the two groups. Researchers will also monitor side effects and collect tumor samples for future research.

After completing the study treatment, patients will have follow-up visits every six months for two years, then once at three years.

Eligibility Criteria

Locations