Pleurectomy/Decortication Followed By Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborators:
Eli Lilly and Company
M.D. Anderson Cancer Center
University of Pennsylvania
Mayo Clinic
Brigham and Women's Hospital
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00715611
First received: July 11, 2008
Last updated: April 14, 2016
Last verified: April 2016
  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 implementation of standard pleurectomy/decortication (removal of the surface lining of the lung) performed at other centers. Patients will undergo pleurectomy/decortication followed by chemotherapy then hemithoracic pleural IMRT to the pleura in patients with malignant pleural mesothelioma.

Condition Intervention Phase
Mesothelioma
Procedure: Pleurectomy/Decortication
Drug: pemetrexed and cisplatin or carboplatin
Radiation: Intensity Modulated Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Toxicity Study of Pleurectomy/Decortication Followed By Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 81
Study Start Date: July 2008
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. 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.
Procedure: Pleurectomy/Decortication
Pleurectomy/decortication will be performed as per standard technique
Other Name: (P/D)
Drug: pemetrexed and cisplatin or carboplatin
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.
Radiation: Intensity Modulated Radiation Therapy
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 Name: IMRT

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Absolute neutrophil count ≥1.5 K/mcL
    2. Platelets ≥100 K/mcL
    3. Serum total bilirubin ≤ 1.5 X ULN
    4. AST (SGOT) or ALT (SGPT) ≤ 3.0 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715611

Contacts
Contact: Andreas Rimner, MD 212-639-6025
Contact: Valerie Rusch, MD 212-639-5873

Locations
United States, New Jersey
Memorial Sloan Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andreas Rimner, MD    212-639-6025      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andreas Rimner, MD    212-639-6025      
Contact: Valerie Rusch, MD    212-639-5873      
Principal Investigator: Andreas Rimner, MD         
Memorial Sloan Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering West Harrison Recruiting
West Harrison, New York, United States, 10604
Contact: Andreas Rimner, MD    212-639-6025      
United States, Texas
Md Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Eli Lilly and Company
M.D. Anderson Cancer Center
University of Pennsylvania
Mayo Clinic
Brigham and Women's Hospital
Investigators
Principal Investigator: Andreas Rimner, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00715611     History of Changes
Other Study ID Numbers: 08-053 
Study First Received: July 11, 2008
Last Updated: April 14, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:
pemetrexed
cisplatin
IMRT
PLEURA
Malignant
08-053

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 28, 2016