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Sponsored by: |
Ohio State University Comprehensive Cancer Center |
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Information provided by: | Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00293579 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer |
Estimated Enrollment: | 36 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharnyx, oropharnyx, 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ohio State University Cancer Clinical Trial Matching Service | 866-627-7616 | osu@emergingmed.com |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Anterpreet Neki, M.D. | Ohio State University |
Responsible Party: | Ohio State University Comprehensive Cancer Center ( Anterpreet Neki, M.D. ) |
Study ID Numbers: | OSU-0482 |
Study First Received: | February 15, 2006 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00293579 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Folic Acid Pemetrexed Head and Neck Neoplasms Folic Acid Antagonists |
Antimetabolites Pemetrexed Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Head and Neck Neoplasms Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |