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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anterpreet Neki, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00293579
First received: February 15, 2006
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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: Allocation: Non-Randomized
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: 6 cycles of therapy ] [ Designated as safety issue: No ]

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)
Intervention Details:
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced, metastatic, or recurrent SCC
  • ECOG PS 2-3

Exclusion Criteria:

  • Prior treatment for recurrent or metastatic disease
  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: NCT00293579

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

Additional Information:
No publications provided by Ohio State University Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anterpreet Neki, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00293579     History of Changes
Other Study ID Numbers: OSU-0482
Study First Received: February 15, 2006
Last Updated: May 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014