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

The Ohio State University

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: Pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT00293579

OSU-0482

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Pemetrexed

Experimental group

Description:

pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles

Treatment:

Drug: Pemetrexed