| Inclusion Criteria: | 1) Patients must have histologically confirmed diagnosis of unresectable malignant pleural mesothelioma. Patients must have either epithelial, sarcomatous or biphasic histologic subtypes.
2) All patients must be 18 years of age or older as AZD2171 increases the hypertrophic zone of the epiphyseal growth plates in animal studies.
3) Patients must have measurable disease per RECIST criteria documented by imaging (CT or MRI) examination within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration.
4) Patients must have had prior systemically administered platinum-based chemotherapy. Patients must have had only one regimen of platinum. Patients may have received more than one drug concurrent with the one allowed platinum-based regimen. Pleural space washing with cisplatin does not constitute systemic administration. One prior chemotherapy regimen only is allowed. Patients must have completed chemotherapy >/= 28 days (42 days for nitrosoureas or mitomycin C) prior to registration and have recovered from adverse events due to agents administered more than 28 days earlier.
5) Patients may have received prior monoclonal antibody therapy directed against VEGF, VEGFRI or VEFGR2.
6) Patients may have received prior surgery (including cytoreductive surgery, if there is residual measurable disease). At least 28 days must have elapsed since the prior surgery (i.e., thoracotomy, laparotomy, or any major surgery, NOT including minor surgeries such as mediastinoscopy, thoracoscopy, or minor biopsies) and the patient has recovered from all associated toxicities.
7) Patients may have received prior radiotherapy, provided that at least 21 days have elapsed since the last treatment and the patient has recovered from all associated toxicities at the time of registration.
8) Patients must have a Zubrod Performance Status of 0 - 2.
9) Patients must have adequate hematologic function as documented by a WBC >/= 3,000/ul, an ANC >/= 1,500/ul and a platelet count >/= 100,000/ul obtained within 28 days prior to registration.
10) Patients must have adequate hepatic function as evidenced by serum bilirubin </= institutional upper limits of normal. SGOT (AST) or SGPT (ALT) must be </= 1.5 x the institutional upper limit of normal. These tests must be obtained within 28 days prior to registration
11) Patients must have a serum creatinine </= 1.5 x the institutional upper limit of normal (IULN) or a measured creatinine clearance >/= 50 mL/min. These tests must be obtained within 28 days prior to registration.
12) Patients must have systolic blood pressure </= 150 mmHg and diastolic blood pressure </= 100 mmHg. Patients on stable antihypertensive therapy are eligible if blood pressure is within this range. Patients enrolled at UTMDACC must have blood pressure to equal or less than 140mmHg/90mmHg.
13) Institutions must have received IRB approval of S9925 (the Lung Cancer Specimen Repository). Patients must be offered participation in S9925. With the patient's consent, blood, plasma and tissue will be submitted for testing via S9925. Patients must be registered separately to S9925 in order for institutions to receive credit for submission.
14) Patients must have an EKG performed and must not have a mean QTc > 470 msec (with Bazett's correction) or have a history of familial long QT syndrome. EKG must be obtained within 14 days prior to registration.
15) All patients must be tested for proteinuria. Patients with 0 -1+ proteinuria are eligible. Patients with greater than I+ proteinuria on two consecutive dipsticks taken no less than 1 week apart are not eligible. Initial testing must be done within 28 days prior to registration.
16) Patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease. Patients must either be able to swallow and/or receive enteral medications via gastrostomy feeding tube.
17) Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
18) No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
19) All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
20) At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.
21) Patients must have a New York Heart Association Classification of I or II. Patients with New York Heart Association Classification of Ior II must be controlled with treatment. |