Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

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Brief Title

Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

Official Title

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

Brief Summary

      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.

Detailed Description

      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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)

Secondary Outcome

 Tumor Change by Baseline Acetylated Tubulin Expression Score

Condition

Squamous Cell Carcinoma

Intervention

Docetaxel

Study Arms / Comparison Groups

 Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Description:  Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

14

Start Date

August 2006

Completion Date

September 2009

Primary Completion Date

September 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically proven squamous cell carcinoma of the oral cavity.

          -  Primary tumor sites eligible: oral cavity. Although they are admittedly of squamous
             cell types, the following tumors will be excluded because their responsiveness to
             chemotherapy may differ: tumors of the nasal and paranasal cavities and of the
             nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor
             biology and management of these tumors is more complex and will likely include upfront
             surgical resection.

          -  Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray,
             abdominal ultrasound, or CT scan (liver function test abnormalities); bone scan in
             case of local symptoms.

          -  At least one uni- or bi-dimensionally measurable lesion.

          -  Age ≥ 18 years.

          -  World Health Organization (WHO) performance status of 2 or less.

          -  No active alcohol addiction.

          -  Final eligibility for a clinical trial is determined by the health professionals
             conducting the trial.

        Exclusion Criteria:

          -  Pregnant or breast feeding

          -  Previous malignancies at other sites, with the exception of adequately treated in situ
             carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other
             cancer curatively treated by surgery and with no evidence of disease for at least 5
             years.

          -  Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.

          -  Patients who experience an involuntary weight loss of more than 25% of their body
             weight in the 2 months preceding study entry.

          -  Concurrent treatment with any other anti-cancer therapy.

          -  Participation in an investigational trial within 30 days of study entry.

          -  Patients with a history of severe hypersensitivity reaction to Taxotere® or other
             drugs formulated with polysorbate 80.

          -  No previous chemotherapy or radiotherapy for any reason and no previous surgery for
             SCCHN [squamous cell carcinoma of the head and neck] (other than biopsy) are allowed
             at the time of study entry.

          -  Final eligibility for a clinical trial is determined by the health professionals
             conducting the trial.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nabil Saba, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00400205

Organization ID

0414-2006

Responsible Party

Principal Investigator

Study Sponsor

Emory University

Collaborators

 Sanofi

Study Sponsor

Nabil Saba, MD, Principal Investigator, Emory University Winship Cancer Institute

Verification Date

October 2017