- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00715611
Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering at Basking Ridge
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack
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Harrison, New York, United States, 10604
- Memoral Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, United States
- Memorial Sloan Kettering at Rockville Center, NY
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- Epithelioid or biphasic histology subtype (Note: patients with biphasic histology can have < 10% sarcomatoid)
- 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 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
- AST (SGOT) or ALT (SGPT) ≤ 3.0 X ULN Note: patients enrolled after chemotherapy do not have to meet the above criteria
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
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
This is a multicenter phase II toxicity study of pleurectomy/decortication (P/D) followed by adjuvant chemotherapy and Intensity Modulated Radiation Therapy (IMRT) to the pleura in patients with malignant pleural mesothelioma.
Alternatively, chemotherapy may be administered in the neoadjuvant setting prior to P/D, followed by IMRT.
Patients deemed resectable at the time of enrollment will undergo P/D with the goal of a macroscopic complete resection (MCR).
Those with disease progression or severe toxicity will stop chemotherapy and undergo a PET scan.
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Pleurectomy/decortication will be performed as per standard technique
Other Names:
The combination of pemetrexed and cisplatin or carboplatin will be given every 3 weeks for up to 4 cycles.
Pemetrexed will be administered at 500mg/m2 as a 10-minute infusion.
Cisplatin will be administered at 75mg/m2 as a 60-minute infusion.
Carboplatin will be administered at an AUC of 5 over 30 minutes.
Chemotherapy may be administered in the neoadjuvant or adjuvant setting.
IMRT will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions with an optional SIB to gross residual disease (pending meeting normal tissue constraints).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients ≥ grade 3 pneumonitis
Time Frame: 2 years
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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.
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2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Annemarie Shepherd, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Carboplatin
- Pemetrexed
Other Study ID Numbers
- 08-053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mesothelioma
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University of ChicagoNational Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Peritoneal Malignant Mesothelioma | Pleural Biphasic Mesothelioma | Pleural Epithelioid Mesothelioma | Pleural Malignant Mesothelioma | Pleural Sarcomatoid Mesothelioma | Recurrent Peritoneal Malignant Mesothelioma | Recurrent Pleural Malignant Mesothelioma and other conditionsUnited States
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National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Stage IA Malignant Mesothelioma | Stage IB Malignant Mesothelioma | Stage II Malignant Mesothelioma | Stage III Malignant Mesothelioma | Stage IV Malignant MesotheliomaUnited States
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National Cancer Institute (NCI)TerminatedEpithelioid Mesothelioma | Sarcomatoid Mesothelioma | Stage IV Pleural Mesothelioma | Recurrent Malignant Mesothelioma | Stage II Pleural Mesothelioma | Stage III Pleural MesotheliomaUnited States
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National Cancer Institute (NCI)CompletedCediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By SurgeryRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Localized Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Localized Malignant MesotheliomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Stage III Pleural Malignant Mesothelioma AJCC v7 | Stage I Pleural Malignant Mesothelioma AJCC v7 | Stage IA Pleural Malignant Mesothelioma AJCC v7 | Stage IB Pleural Malignant Mesothelioma AJCC v7 | Stage II Pleural Malignant Mesothelioma AJCC...United States
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Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Stage IA Malignant Mesothelioma | Stage IB Malignant Mesothelioma | Stage II Malignant Mesothelioma | Stage III Malignant Mesothelioma | Stage IV Malignant MesotheliomaUnited States
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ProgenaBiomeRecruitingMesothelioma | Mesotheliomas Pleural | Mesothelioma Peritoneum | Mesothelioma Malignant | Mesothelioma; Lung | Mesothelioma; Liver | Mesothelioma; OmentumUnited States
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National Cancer Institute (NCI)Active, not recruitingEpithelioid Mesothelioma | Pleural Malignant Mesothelioma | Sarcomatoid Mesothelioma | Recurrent Malignant MesotheliomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous MesotheliomaUnited States
Clinical Trials on Pleurectomy/Decortication
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Royal Brompton & Harefield NHS Foundation TrustUniversity of Bristol; National Institute for Health Research, United KingdomUnknown
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Papworth Hospital NHS Foundation TrustLondon School of Hygiene and Tropical Medicine; King's College London; University... and other collaboratorsCompletedMalignant Pleural Mesothelioma | Trapped LungUnited Kingdom
-
University of BirminghamCompletedPalatally Impacted CaninesUnited Kingdom
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Mashhad University of Medical SciencesCompleted
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Ain Shams UniversityRecruiting
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European Organisation for Research and Treatment...Active, not recruitingMalignant Pleural MesotheliomaBelgium, Netherlands
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Otto-von-Guericke University MagdeburgGerman Research FoundationActive, not recruitingPneumothorax | Recurrent PneumothoraxGermany
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Krishnadevaraya College of Dental Sciences & HospitalCompletedPeriodontal Intrabony Defects
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RenJi HospitalUnknownKidney Diseases,CysticChina
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Shanghai Zhongshan HospitalRecruitingInfections | Pacemaker ComplicationChina