Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck
NCT ID: NCT01333696
Last Updated: 2013-03-05
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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UNKNOWN
PHASE2
32 participants
INTERVENTIONAL
2011-04-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pemetrexed
500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity
Pemetrexed
Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks
Interventions
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Pemetrexed
Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck
* Prior exposure of at least one line of platinum-containing regimen
* At least one site of measurable disease according to RECIST criteria
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
* Liver function: total bilirubin, ALT and AST \<1.5×UNL
* Renal function: Cr\<1.5×UNL, CCR≧45ml/min
Exclusion Criteria
* Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Significant active infection
* Pregnant or lactating women
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Ye Guo
Dr.
Principal Investigators
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Ye Guo, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HNTG 11-01
Identifier Type: -
Identifier Source: org_study_id
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