A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)
Summary
The purpose of this study is to determine if the combination of 2 chemotherapy drugs called pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell cancer. The researchers want to find out what effects, good and/or bad, that this treatment has on head and neck cancer.
Description
Pemetrexed (500 mg/m2) and gemcitabine (1250 mg/m2) will be given together on Days 1 and 15 of a 28 day cycle in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Patients will not have received more than 2 prior chemotherapy regimens in the recurrent/metastatic disease setting. Vitamin B12 and folate supplementation will be administered per standard guidelines for pemetrexed chemotherapy.
The primary endpoint is the objective radiologic response rate. Radiologic imaging of evaluable disease will take place after every 2 cycles. Patients may remain on study until progression of disease or unacceptable toxicity.
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Head and Neck Cancer
Intervention
Pemetrexed plus Gemcitabine
Location
Memorial Sloan-Kettering Cancer Center
New York
New York
United States
10065
Status
Completed
Source
Memorial Sloan-Kettering Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00589667
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Head And Neck Neoplasms
Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)
Neck Dissection
Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.
Rhabdomyosarcoma, Embryonal
A form of RHABDOMYOSARCOMA arising primarily in the head and neck, especially the orbit, of children below the age of 10. The cells are smaller than those of other rhabdomyosarcomas and are of two basic cell types: spindle cells and round cells. This cancer is highly sensitive to chemotherapy and has a high cure rate with multi-modality therapy. (From Holland et al., Cancer Medicine, 3d ed, p2188)
Torticollis
A symptom, not a disease, of a twisted neck. In most instances, the head is tipped toward one side and the chin rotated toward the other. The involuntary muscle contractions in the neck region of patients with torticollis can be due to congenital defects, trauma, inflammation, tumors, and neurological or other factors.
Brachiocephalic Veins
Large veins on either side of the root of the neck formed by the junction of the internal jugular and subclavian veins. They drain blood from the head, neck, and upper extremities, and unite to form the superior vena cava.
Clinical Trials
Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer
The purpose of this study is to look at how well the combination of two chemotherapy drugs, pemetrexed (Alimta) and gemcitabine (Gemzar) work to treat your cancer.
Study of Pemetrexed and Bevacizumab in Patients With Head and Neck Cancer
The purpose of this study is to determine if the combination of two new drugs pemetrexed (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck ca...
The purposes of this study are to determine: 1. The safety of pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs....
The purposes of this study are to determine: 1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs....
Trial of Cetuximab and Pemetrexed With Radiation in Head and Neck Cancer
The purpose of this Phase I study is to determine the safety and effectiveness of two chemotherapies drugs, Cetuximab and Pemetrexed (Alimta), when given in combination with radiation ther...
PubMed Articles
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ABSTRACT: BACKGROUND: Based on their different mechanisms of action, non-overlapping side effects and radiosensitising potential, combining the antimetabolites pemetrexed (multitargeted antifolate, MT...
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