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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Fudan University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT01333696
First received: April 11, 2011
Last updated: March 2, 2013
Last verified: March 2013
  Purpose
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 Intervention Phase
Squamous Cell Carcinoma of Head and Neck
Drug: Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Median overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: April 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333696

Locations
China
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, MD Fudan University
  More Information

Responsible Party: Ye Guo, Dr., Fudan University
ClinicalTrials.gov Identifier: NCT01333696     History of Changes
Other Study ID Numbers: HNTG 11-01 
Study First Received: April 11, 2011
Last Updated: March 2, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Squamous cell carcinoma of head and neck
Pemetrexed

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 09, 2016