Primary Outcome
- number of patients ≥ grade 3 pneumonitis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Grade 3 pneumonitis is defined as symptomatic, interfering with ADL’s and requiring oxygen support as defined by the NCI Common Terminology Criteria (CTC) version 4.0 for toxicity and Adverse Event reporting.
Eligibility
- Inclusion Criteria
- Provide written informed consent to participate on the study
- Patients must have a pathologically confirmed diagnosis either at MSKCC or at the participating site of stage I-III malignant pleural mesothelioma amenable to P/D.
- Epithelioid or biphasic histology subtype
- No evidence of metastatic disease.
- Patient age ≥ 18 years but ≤ 80 years at the time of consent.
- Karnofsky performance status ≥ 80%
- Pulmonary Function Tests: 1. FEV1 ≥ 35% (corrected for Hgb) of predicted postoperative (ppoFEV1) (as if the patient underwent a pneumonectomy) based on the following formula using the quantitative V/Q scan: °Predicted post-resection FEV1 = FEV1 x % perfusion to uninvolved lung from the quantitative V/Q scan report
- DLCO > 40% predicted (corrected for Hgb)
- Patient must have adequate organ function as indicated by the following laboratory values:
- Absolute neutrophil count ≥1.5 K/mcL
- Platelets ≥100 K/mcL
- Serum total bilirubin ≤ 1.5 X ULN
- Serum total bilirubin ≤ 1.5 X ULN
- In cases of concern about renal toxicity from chemotherapy, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.
- Reassessment after P/D: Confirmation of resection status postoperatively, prior to proceeding with adjuvant chemotherapy and pleural IMRT
- Exclusion Criteria
- Sarcomatoid or desmoplastic histology
- Continuous oxygen use
- Prior nephrectomy on the contralateral side of MPM
- Prior systemic therapy (e.g. chemotherapy/biological agents) for mesothelioma
- Prior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of P/D
- Prior thoracic radiation therapy preventing hemithoracic pleural IMRT
- Bulky disease in the fissure preventing lung-sparing pleural IMRT
- Patients undergoing extrapleural pneumonectomy
- Patients with an active infection that require systemic antibiotics, antiviral, or antifungal treatments
- Patients with a concurrent active malignancy (except squamous or basal cell carcinoma of the skin)
- Patients with serious unstable medical illness
- Presence of third space fluid that cannot be controlled by drainage
- For patients who develop or have baseline clinically significant pleural effusions before or during initiation of pemetrexed therapy; consideration should be given to drain the effusion prior to dosing
- No acute congestive heart failure
- Pregnant or lactating women
- Men or women not using effective contraception
Reproductive risks Patients should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breast-feed a baby while on this study. Women of childbearing age will be counseled to use birth control while on this study.
