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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pemetrexed

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

Group Type EXPERIMENTAL

Pemetrexed

Intervention Type DRUG

500 mg/m2 IV every 3 weeks for 6 cycles

Interventions

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Pemetrexed

500 mg/m2 IV every 3 weeks for 6 cycles

Intervention Type DRUG

Other Intervention Names

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ALIMTA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No