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Clinical Trial 19685

Cancer Type: Thoracic
Interventions:Alimta (Pemetrexed); Paraplatin (carboplatin); Pemetrexed; carboplatin; cisplatin

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Bradford Perez

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase II Toxicity Study of Pleurectomy/Decortication, (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients with Locally Advanced Malignant Pleural Mesothelioma

Summary

Objective

2.1 Primary Objective - To determine the safety and exportability of the MSKCC trimodality approach consisting of pleurectomy/decortication, adjuvant chemotherapy (neoadjuvant chemotherapy permissible as an alternative) and IMRT to the pleura in patients with malignant pleural mesothelioma as indicated by the incidence of > grade 3 pneumonitis in a multi-institutional setting. 2.2 Secondary Objectives - To determine the progression free and overall survival rates of patients with malignant pleural mesothelioma treated with lung-sparing trimodality therapy to the pleura - To determine the pattern of progression: local recurrence versus metastatic disease - To determine the incidence of any IMRT-related grade 2 or greater toxicity - To determine the impact of trimodality therapy and pleural IMRT on patient-reported outcomes (PRO-CTCAE) - To develop a prediction model of resectability and a prognostic multi-modality imaging model through MRI, PET and CT imaging

Inclusion Criteria

  • Patients must have a pathologically confirmed diagnosis either at MSKCC or at the participating site of stage I-III malignant pleural mesothelioma
  • Epithelioid or biphasic histology subtype (Note: patients with biphasic histology can have > No evidence of metastatic disease.
  • Patient age ≥ 18 years but ≤ 80 years at the time of consent.
  • Karnofsky performance status ≥ 80%
  • Pulmonary Function Tests: For all patients: DLCO > 40% predicted (corrected for Hgb) For patients enrolled post-P/D, only: FEV1 >/= 35% (corrected for Hgb) (Note: patients enrolled prior to P/D will have PFTs repeated pre-IMRT. If this criteria is not met, they will be removed from study)
  • In cases of concern about decreased renal function and potential high radiation dose to the kidneys, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.
  • Patient enrolled prior to chemotherapy must have adequate organ function.

  • Exclusion Criteria

  • > 10% Sarcomatoid or desmoplastic histology
  • Continuous oxygen use
  • Prior nephrectomy on the contralateral side of MPM
  • Prior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of P/D (i.e.: intrapleural chemotherapy, photodynamic therapy, intrapleural betadine)
  • 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 chemotherapy administration
  • No acute congestive heart failure
  • Pregnant or lactating women
  • Men or women not using effective contraception