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Clinical Trial Details

Overview

Research Study Summary

A clinical research study of Pemetrexed + Cisplatin or Carboplatin AUC=5 Pleurectomy/decortication (if feasible) Intensity Modulated Radiation Therapy for the treatment of Mesothelioma

Research Study Title

Phase II Toxicity Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma.

Purpose

For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and toxicity of standard chemotherapy +/-pleurectomy/decortication followed by IMRT to the pleura in patients with malignant pleural mesothelioma.

To Learn more
Phase

2

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Memorial Sloan-Kettering Cancer Center

Duration

96 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Patients must have a pathologically confirmed diagnosis either at MSKCC or at the participating site of malignant pleural mesothelioma.

  • No evidence of metastatic disease.

  • No prior chemotherapy for mesothelioma.

  • No prior radiation therapy except for localized prostate or pelvic radiation

  • Patient age ≥ or = to 18 years on day of signing informed consent.

  • Karnofsky performance status ≥ or = to 70%

  • Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.

  • Patient must have the ability to interrupt NSAIDS 2 days before (5 days for longacting NSAIDs), the day of, and 2 days following administration of pemetrexed.

  • Pulmonary Function Tests:

  • FEV1 ≥ 30% 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 > 35% predicted

  • Patient must have adequate organ function as indicated by the following laboratory values:

  • Hematological:

  • Absolute neutrophil count ≥ or = to 1,500 /mcL

  • Platelets ≥ or = to 100,000 / mcL

  • Renal Calculated creatinine clearance (CrCl) ≥ or = to 45 mL/min (Creatinine clearance must be calculated using Cockcroft & Gault method) In cases of concern about renal toxicity from IMRT, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.

  • Hepatic

  • Serum total bilirubin ≤ or = to 1.5 X upper limit of normal (ULN) AST (SGOT) or ALT (SGPT) ≤ or = to 3.0 X ULN

Exclusion Criteria:

  • Pregnant or lactating women, or men or women not using effective contraception.

  • Patients with resectable disease for whom extrapleural pneumonectomy is necessary.

  • Patients with an active infection that require systemic antibiotics, antiviral, or antifungal treatments.

  • Patients with a concurrent active malignancy.

  • 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 draining the effusion prior to dosing.

  • No acute congestive heart failure

Site Locations (6)

Country State City Zip Facility and Contact
United States New Jersey Basking Ridge 07920 Memorial Sloan-Kettering at Basking Ridge
Lee Krug, MD
646-888-4201
United States New York Commack 11725 Memorial Sloan-Kettering Cancer Center @ Suffolk
Lee Krug, MD
646-888-4201
United States New York New York 10065 Memorial Sloan-Kettering Cancer Center
Lee Krug, MD
646-888-4201

Lee Krug, MD
Principal Investigator
United States New York Rockville Centre Memorial Sloan-Kettering at Mercy Medical Center
Lee Krug, MD
646-888-4201
United States New York Sleepy Hollow 10591 Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Lee Krug, MD
212-639-8420
United States Texas Houston 77030 Md Anderson Cancer Center
Daniel Gomez, MD

Daniel Gomez, MD
Principal Investigator

Contact

Lee Krug, MD
646-888-4201

NCT ID: NCT00715611

Date Last Changed: February 10, 2014

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