Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy
Conditions
Mesothelioma
Conditions: official terms
Mesothelioma
Conditions: Keywords
pemetrexed, cisplatin, IMRT, PLEURA, Malignant, 08-053
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pemetrexed + Cisplatin or Carboplatin AUC=5 Pleurectomy/decortication (if feasible) Intensity Modulated Radiation Therapy
Type: Other
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Status: Recruiting
Contact: Lee Krug, MD - 646-888-4201
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Status: Recruiting
Contact: Lee Krug, MD - 646-888-4201
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Lee Krug, MD - 646-888-4201
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Status: Recruiting
Contact: Lee Krug, MD - 646-888-4201
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States
Status: Recruiting
Contact: Lee Krug, MD - 212-639-8420
Md Anderson Cancer Center
Houston, Texas, United States
Status: Active, not recruiting
Start Date
July 2008
Completion Date
July 2016
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page