Trial Information

A Phase II Study of Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer

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.