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Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer

This study has been completed.
Information provided by (Responsible Party):
Anterpreet Neki, Ohio State University Comprehensive Cancer Center Identifier:
First received: February 15, 2006
Last updated: February 11, 2016
Last verified: February 2016
This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.

Condition Intervention Phase
Head and Neck Cancer
Drug: Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer

Resource links provided by NLM:

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures:
  • Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  • Impact of Pemetrexed Chemotherapy on Quality of Life [ Time Frame: Baseline, End of Treatment [up to 3 years] ] [ Designated as safety issue: Yes ]
    Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health).

  • Overall Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Overall survival was measured from the time of initial study entry to death due to any cause.

Enrollment: 5
Study Start Date: February 2006
Study Completion Date: November 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
Drug: Pemetrexed
500 mg/m2 IV every 3 weeks for 6 cycles
Other Name: ALIMTA

Detailed Description:

Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. The possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation. The current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer. Researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers, including head and neck cancer with a response rate that is similar to other single chemotherapy drugs. In addition, previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and B12 vitamin supplementation. Along with pemetrexed, the current study provides study participants with both folic acid and B12.

Purpose: The primary objective of this study is to evaluate tumor response, including complete and partial remission, and toxicities from pemetrexed in patients with advanced head and neck cancer. Secondary objectives of this study include measurements of time to tumor progression, survival, and patient quality of life.

Treatment: Study participants will be given pemetrexed through intravenous infusions. Pemetrexed will be administered once every three weeks. This schedule of pemetrexed once every three weeks will be repeated up to six times. Study participants will also be provided with both folic acid and B12 vitamin supplementation before, during, and after study treatments with pemetrexed. Vitamin supplementation is considered critical and compliance must be followed closely. Several tests and exams will be given throughout the study to monitor patients. Treatments will be discontinued due to disease growth and unacceptable side effects.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Advanced, metastatic, or recurrent head and neck cancers
  • Poor risk patients with ECOG performance status of 2

Exclusion Criteria:

  • Prior treatment for recurrent or metastatic disease
  • No clinical or radiological evidence of brain metatases
  • Patients with bone only disease are not eligible
  • Patients with pleural or peritoneal effusion as only manifestation of diesase
  Contacts and Locations
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Please refer to this study by its identifier: NCT00293579

United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Principal Investigator: Anterpreet Neki, M.D. Ohio State University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anterpreet Neki, Principal Investigator, Ohio State University Comprehensive Cancer Center Identifier: NCT00293579     History of Changes
Other Study ID Numbers: OSU-0482 
Study First Received: February 15, 2006
Results First Received: October 30, 2015
Last Updated: February 11, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on October 21, 2016