Head and Neck Cancer Clinical Trial
Official title:
A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have microscopically confirmed epidermoid/squamous cell carcinoma (HNSCC) of the oral cavity, pharynx, larynx, paranasal sinus, or head/neck squamous cell carcinoma unknown primary. - Patients must have recurrent or metastatic disease which is not amenable to curative-intent therapy with surgery or radiation. - No more than 2 prior cytotoxic therapies in the recurrent or metastatic disease setting are permitted. - Patients must be at least 18 years of age. - Karnofsky Performance status must be = 70%. - Disease must be measurable by RECIST criteria. - At least 4 weeks must have elapsed from previous radiation therapy. Patient must have recovered from the acute toxic effects of treatment prior to study enrollment. - Prior radiation therapy to = 25% of bone marrow is allowed. Prior radiation to the whole pelvis and/or brain is not allowed. - Adequate organ function - Patients of childbearing potential must have a negative test for pregnancy at time of enrollment based on a urine or serum pregnancy test. Patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug. - Patient must reside in geographic proximity to MSKCC for adequate follow-up during treatment, per investigator discretion. - Patients must sign an informed consent document. Exclusion Criteria: - Previous exposure to pemetrexed (Alimta) or gemcitabine (Gemzar). - Pregnancy or breast-feeding. - Serious concomitant systemic disorders (for example, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study. - History of any brain metastases. - Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone. - Patients will be excluded if they will be unable to hold use of nonsteroidal antiinflammatory agents (NSAIDS) with short elimination half lives |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Objective Response | To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
2 years | No |
Secondary | Median Overall Survival | To determine the median overall survival for patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma treated with pemetrexed and gemcitabine. | 2 years | No |
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