Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma
NCT ID: NCT02639767
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pemetrexed/cisplatin with pleural IMRT
This is a single institution phase I study of pemetrexed/cisplatin given concurrently with pleural intensity modulated radiation therapy (IMRT) in patients with unresectable malignant pleural mesothelioma (MPM). All patients will receive pleural intensity modulated radiation therapy (IMRT). Patients will be enrolled in cohorts of 3-6 at each dose level of pemetrexed/cisplatin, and dose escalation will proceed in a standard 3+3 fashion until the maximum tolerated dose (MTD) is identified.
Pemetrexed/Cisplatin
Dose escalation of pemetrexed and cisplatin will follow the dose levels. The escalation will not exceed 500 mg/m\^2 for pemetrexed in combination with 75 mg/m\^2 of cisplatin even if the maximum tolerated dose is not identified. Each treatment cycle of chemotherapy will be 21 days. Patients will receive up to 2 cycles of chemotherapy during the radiation, and be followed for any DLT during the radiation therapy and for 12 weeks afterwards.
Pleural Intensity Modulated Radiation Therapy
Pleura intensity modulated radiation therapy (IMRT) will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions. The prescription radiation dose may anywhere between 45 and 50.4 Gy in 25 fractions if necessary to meet the normal tissue dose constraints.
MRI
A pre-treatment MRI before chemo-RT will be acquired and will be used for target delineation. A three month post-treatment MRI will be acquired with the same protocol to assess the response from concurrent chemo-RT.
Interventions
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Pemetrexed/Cisplatin
Dose escalation of pemetrexed and cisplatin will follow the dose levels. The escalation will not exceed 500 mg/m\^2 for pemetrexed in combination with 75 mg/m\^2 of cisplatin even if the maximum tolerated dose is not identified. Each treatment cycle of chemotherapy will be 21 days. Patients will receive up to 2 cycles of chemotherapy during the radiation, and be followed for any DLT during the radiation therapy and for 12 weeks afterwards.
Pleural Intensity Modulated Radiation Therapy
Pleura intensity modulated radiation therapy (IMRT) will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions. The prescription radiation dose may anywhere between 45 and 50.4 Gy in 25 fractions if necessary to meet the normal tissue dose constraints.
MRI
A pre-treatment MRI before chemo-RT will be acquired and will be used for target delineation. A three month post-treatment MRI will be acquired with the same protocol to assess the response from concurrent chemo-RT.
Eligibility Criteria
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Inclusion Criteria
* No plans for surgical resection
* Stage T1-4, N0-3, M0
* No prior radiation therapy to the chest, breast or supraclavicular fossa that would limit radiation delivery to the full prescription dose
* Prior chemotherapy regimens ≤1
* Age ≥18 years
* Karnofsky performance status ≥ 80%
* Pulmonary function tests as follows: DLCO\>50% predicted
* Adequate hematologic, hepatic, and renal function as indicated by the following laboratory values
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Calculated creatinine clearance (CrCl) ≥ 45mL/min (using Cockcroft \& Gault method)
* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless known Gilbert's disease)
* AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN
Exclusion Criteria
* Patients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatments
* Patients with a concurrent active malignancy (with the exception of skin cancer)
* Patients with serious unstable medical illness
* Patients with idiopathic pulmonary fibrosis
* Patients with NYHA heart failure class \>2
* Patients with only one kidney that is ipsilateral to the mesothelioma
* Implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be moved
* Metallic implant, e.g. pacemaker, defibrillator
* Unmanageable claustrophobia
* High risk for nephrogenic systemic fibrosis
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Marjorie Zauderer
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Memorial Sloan Kettering West Harrison
East White Plains, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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15-304
Identifier Type: -
Identifier Source: org_study_id