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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293579
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : March 10, 2016
Last Update Posted : February 10, 2020
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Pemetrexed Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
Actual Study Start Date : February 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 3 years ]
    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 :
  1. 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 ]
    Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

  2. Impact of Pemetrexed Chemotherapy on Quality of Life [ Time Frame: Baseline, End of Treatment [up to 3 years] ]
    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).

  3. Overall Survival [ Time Frame: Up to 2 years ]
    Overall survival was measured from the time of initial study entry to death due to any cause.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00293579

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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
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Principal Investigator: Anterpreet Neki, M.D. Ohio State University
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ohio State University Comprehensive Cancer Center Identifier: NCT00293579    
Other Study ID Numbers: OSU-0482
First Posted: February 17, 2006    Key Record Dates
Results First Posted: March 10, 2016
Last Update Posted: February 10, 2020
Last Verified: January 2020
Keywords provided by Ohio State University Comprehensive Cancer Center:
head and neck cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors