Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck
Primary Purpose
Squamous Cell Carcinoma of Head and Neck
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck focused on measuring Squamous cell carcinoma of head and neck, Pemetrexed
Eligibility Criteria
Inclusion Criteria:
- Age range: 18-65 years old
- 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:
- With curable treatment option
- 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
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pemetrexed
Arm Description
500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
Median progression-free survival
Median overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01333696
Brief Title
Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck
Official Title
Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.
Detailed Description
The treatment option in patients with platinum-resistant relapsed or metastatic squamous cell carcinoma of head and neck is limited. Previous randomized phase III study showed a borderline benefit of pemetrexed added to cisplatin. Therefore, we aim to evaluate the efficacy of pemetrexed in salvage setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Head and Neck
Keywords
Squamous cell carcinoma of head and neck, Pemetrexed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pemetrexed
Arm Type
Experimental
Arm Description
500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Median progression-free survival
Time Frame
1 year
Title
Median overall survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range: 18-65 years old
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:
With curable treatment option
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Guo, MD
Phone
86 21 64175590
Ext
8906
Email
pattrick_guo@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Phone
86 21 64175590
Ext
8906
Email
pattrick_guo@msn.com
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
12. IPD Sharing Statement
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Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck
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