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Therapeutic Areas: Oncology
Disease Category: Mesothelioma
Location: United States, IL
Clinical Trial Details
Research Study Summary
SWOG S0905 Phase I/II Randomized Study of Pemetrexed Disodium and Cisplatin With Versus Without Cediranib Maleate in Patients With Malignant Pleural Mesothelioma
Why is this study being done?
One of the standard treatment options for your type of cancer is cisplatin and pemetrexed. Cediranib is an experimental cancer drug. It is currently being tested in cancer patients. There are laboratory results that suggest that cisplatin and pemetrexed might work better if cediranib is added. This study is being done to find the best dose of cediranib when used with cisplatin and pemetrexed and to test the safety of giving all three drugs together. This study will be conducted in two parts. Patients will take part in either Part I or Part II, but not both. In the first part of the study, patients will be treated with cediranib along with cisplatin and pemetrexed. If this cediranib dose causes bad side effects, it will be decreased as new patients take part in the study. Once the maximum safe dose of cediranib is decided, the first part of the study will end and the second part of the study will start.
In the second part of the study, patients will be treated with cisplatin and pemetrexed. In addition, about half of the patients will also receive cediranib (at the dose as determined in the first part of the study). The other half of the patients will receive a placebo (a substance containing no medication or a preparation used as a control in an experiment to determine the effectiveness of a medicinal drug).
Patient Inclusion Criteria:
- Histologically confirmed malignant pleural mesothelioma (MPM).
- No surgical resection planned. No prior systemic tx for MPM.
- Prior systemic tx allowed as neoadjuvant or adjuvant tx if disease has recurred and tx was completed > 6 months prior to reg.
- Prior tx must not have included cediranib.
- May have received prior surgery provided at least 28 days have elapsed since thoracic or other major surgeries and pts have recovered from all toxicities.
- No anticipated need for major surgeries during protocol tx.
- May have received prior RT provided at least 28 days have elapsed and pts have recovered from all toxicities.
- Zubrod 0-2. No QTc > 500 msec, other significant ECG abnormality, NYHA classification III or IV.
- Able to swallow oral meds.
Patient Exclusion Criteria:
- Must not be receiving any medication that may markedly affect renal function.
- No clinically significant hemoptysis within one year prior to reg.
- No known HIV infection.
- No pregnant or nursing women
- No plans to receive concurrent chemo, hormonal therapy, RT, immunotherapy or any other type of tx for cancer while on protocol tx
- o other prior malignancy except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the pt is currently in complete remission, or any other cancer from which the pt has been dz free for 5 years.
To Learn more
Both Male and Female
Date Last Changed:
July 17, 2013
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