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Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Eli Lilly and Company
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00715611
First received: July 11, 2008
Last updated: August 4, 2014
Last verified: August 2014

July 11, 2008
August 4, 2014
July 2008
July 2016   (final data collection date for primary outcome measure)
To determine the safety of chemotherapy +/- pleurectomy/decortication followed by IMRT to the pleura in patients with malignant pleural mesothelioma as indicated by the incidence of grade 3 or greater pneumonitis. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
To determine the safety (specifically in regards to pneumonitis) of chemotherapy followed by IMRT in patients with unresectable malignant pleural mesothelioma. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00715611 on ClinicalTrials.gov Archive Site
  • To determine the response rate, progression free and overall survival rates of patients with malignant pleural mesothelioma treated with chemotherapy, with or without P/D, followed by IMRT to the pleura. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine the relationship between response to treatment and the levels of soluble mesothelin-related peptide (SMRP) and osteopontin. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine the pattern of progression: local recurrence versus metastatic disease. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine the incidence of any grade 3 or greater toxicity. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    This study will utilize the Common Terminology Criteria (CTC) version 4.0 for toxicity and Adverse Event reporting.
  • The response rate, progression free and overall survival rates of patients with unresectable malignant pleural mesothelioma treated with chemotherapy followed by IMRT to the pleura. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine the relationship between response to treatment and the levels of soluble mesothelin-related peptide (SMRP) and osteopontin. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine the pattern of progression: local recurrence versus metastatic disease. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy
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.

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mesothelioma
Other: Pemetrexed + Cisplatin or Carboplatin AUC=5 Pleurectomy/decortication (if feasible) Intensity Modulated Radiation Therapy
Patients who are potential candidates for pleurectomy/decortication (P/D) at the time of enrollment will receive up to four cycles of pemetrexed (500mg/m2) and cisplatin (75mg/m2) or carboplatin (AUC=5) every 3 weeks. Four to six weeks later chemotherapy, P/D will be attempted and within 8 weeks they will start treatment they will be treated with IMRT, 50.4 Gy in 28 fractions.
Experimental: 1
This is a multicenter institution phase II toxicity study of chemotherapy +/- Pleurectomy/Decortication (P/D) followed by Intensity Modulated Radiation Therapy (IMRT) to the pleura in patients with malignant pleural mesothelioma. Patients will receive up to four cycles of pemetrexed (500mg/m2) and cisplatin (75mg/m2 ) or carboplatin (AUC=5) every 3 weeks. After completion of the chemotherapy, patients who are potential candidates for pleurectomy/decortication (P/D) at the time of enrollment will have this performed and within eight weeks from surgery they will be treated with IMRT, 50.4 Gy in 28 fractions. If patients have unresectable disease, they will be treated with IMRT, 50.4 Gy in 28 fractions after completion of the chemotherapy.
Intervention: Other: Pemetrexed + Cisplatin or Carboplatin AUC=5 Pleurectomy/decortication (if feasible) Intensity Modulated Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
July 2016
July 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Lee Krug, MD 646-888-4201
Contact: Andreas Rimner, MD 212-639-6025
United States
 
NCT00715611
08-053
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Eli Lilly and Company
  • M.D. Anderson Cancer Center
Principal Investigator: Lee Krug, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP