Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Fluorouracil

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.

Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.

Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.

5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.

5-fluorouracil

Nabil Saba, MD

This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.

This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.

Approximately 60 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute in Atlanta, Georgia.

Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

Phase II Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Chemotherapy in Squamous Cell Carcinoma of the Oral Cavity With Molecular Endpoints

Complete remission (complete disappearance of disease), partial remission \[more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)\].

Percent change in TNM stage of tumors after three cycles of study treatment was assessed to see if baseline acetylated tubulin (AT) expression predicts treatment success. Decreasing tumor stage change (a negative number) indicates that the tumor is responding to treatment while an increase means that the severity of the tumor is not decreasing. Immunohistochemistry (IHC) analysis of AT expression was performed in formalin-fixed, paraffin-embedded, pre-treatment tissues. The staining was scored based upon intensity according to the following criteria: 0=no staining, 1+=weak tumor staining, 2+=moderate tumor staining, 3+=moderate to high tumor staining, and 4+=high tumor staining.

Data presented are adopted from Saba, NF, et. al. Acetylated Tubulin (AT) as a Prognostic Marker in Squamous Cell Carcinoma of the Head and Neck. Head and Neck Pathology (2014) 8:66-72.

Sanofi

Emory University

Professor

Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.

Recipients of Docetaxel, Cisplatin, 5-Fluorouracil

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Cancer stage was assessed with the tumor, node and metastasis (TNM) staging system. The TNM Classification of Malignant Tumors is a commonly used system of assessing cancer severity. Stage IV refers to cancer that has spread to distant body parts and is the most severe stage.

Tumor Stage IV

Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatin, and 5-fluorouracil

Spots Global Cancer Trial Database for Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

Trial Identification

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Study Description

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