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Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck

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ClinicalTrials.gov Identifier: NCT01333696
Recruitment Status : Unknown
Verified March 2013 by Ye Guo, Fudan University.
Recruitment status was:  Recruiting
First Posted : April 12, 2011
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck Drug: Pemetrexed Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck
Study Start Date : April 2011
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pemetrexed
500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity
 Drug: Pemetrexed
Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks
Other Name: Alimta


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Median progression-free survival [ Time Frame: 1 year ]
  2. Median overall survival [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333696


Contacts
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Contact: Ye Guo, MD 86 21 64175590 ext 8906 pattrick_guo@msn.com

Locations
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China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Contact: Ye Guo, MD    86 21 64175590 ext 8906    pattrick_guo@msn.com   
Principal Investigator: Ye Guo, MD         
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Ye Guo, MD Fudan University
More Information
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Responsible Party: Ye Guo, Dr., Fudan University
ClinicalTrials.gov Identifier: NCT01333696    
Other Study ID Numbers: HNTG 11-01
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013
Keywords provided by Ye Guo, Fudan University:
Squamous cell carcinoma of head and neck
Pemetrexed
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
 Neoplasms by Site
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors