Head and Neck Cancer Clinical Trial
Official title:
A Phase II Study of Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
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.
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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