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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00541073 |
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Date of registration:
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05/10/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by Surgery
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Scientific title:
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Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00541073 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Amelie Lansiaux, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Oscar Lambret |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
Inclusion criteria:
- Histologically confirmed pleural mesothelioma
- Unresectable disease
Exclusion criteria:
- Clinically detected pleural effusion or ascites that cannot be controlled by drainage
or other procedures
PATIENT CHARACTERISTICS:
Inclusion criteria:
- WHO performance status 0-2
- Life expectancy > 3 months
- Absolute neutrophil count = 1,500/mm^3
- Platelet count = 100,000/mm^3
- Creatinine clearance > 45 mL/min
- Total bilirubin = 1.5 times upper limit of normal (ULN)
- Transaminases = 3 times ULN (5 times ULN if liver metastases)
- Not pregnant or nursing
- Fertile patients of must use effective contraception during and for 6 months after
completion of study treatment
Exclusion criteria:
- Hypersensitivity to pemetrexed disodium or any of its excipients
- Peripheral neuropathy = grade 2
- Impossible to receive study therapy due to geographical, social, familial, or
psychological reasons
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- At least 28 days since prior radiotherapy (21 days for injected radiotherapy)
Exclusion criteria:
- Prior chemotherapy
- Prior yellow fever vaccine
- Inability to discontinue aspirin (> 1.3 g/day) or NSAIDs for 2 days prior to, during,
and 2 days after day 1 of each course of study therapy
- Concurrent participation in another clinical study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malignant Mesothelioma
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Intervention(s)
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Drug: pemetrexed disodium
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Other: laboratory biomarker analysis
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Drug: cisplatin
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Other: pharmacological study
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Dietary Supplement: vitamin B12
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Genetic: gene expression analysis
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Primary Outcome(s)
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Individual dosage-adapted protocol
[Time Frame: No]
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Secondary Outcome(s)
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Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD)
[Time Frame: No]
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Relationship between pharmacokinetic and pharmacodynamic parameters
[Time Frame: No]
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Pharmacokinetics
[Time Frame: No]
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Secondary ID(s)
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COL-ALIMESO
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COL-2006-04
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CDR0000564058
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INCA-RECF0441
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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