A Phase I / Randomized Phase II Study of Cediranib (NSC #732208) Versus Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural Mesothelioma

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. Must seek additional patient consent for banking and future use of specimens. Zubrod 0-2. No QTc > 500 msec, other significant ECG abnormality, NYHA classification III or IV. Must not require concurrent use of drugs or biologics with proarrhythmic potential. Must not be receiving any medication that may markedly affect renal function. No clinically significant hemoptysis within one year prior to reg. Able to swallow oral meds. 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. No 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. Within 28 days prior to reg: assessment of measurable dz; ANC >/= 1,500 mcl; platelets >/=100,000/mcl; hemoglobin >/=9.0 g/dl; bilirubin <\= 1.5 x IULN; SGOT or SGPT </= 2.5 x IULN (if liver mets, SGOT or SGPT </= 5 x IULN); serum creatinine </= 1.5 x IULN; calculated creatinine clearance >/= 60 mL/min; urine dipstick. Within 42 days prior to reg: assessment of non-measurable dz; ECG