Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

This study has been terminated.
(Safety reasons)
Sponsor:
Collaborator:
Sanofi
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00400205
First received: November 15, 2006
Last updated: March 30, 2011
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Squamous Cell Carcinoma
Oral Cancer
Drug: Taxotere
Drug: Cisplatin
Drug: 5-fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Chemotherapy in Squamous Cell Carcinoma of the Oral Cavity With Molecular Endpoints

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors) [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
    Complete remission (complete disappearance of disease), partial remission [more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)].


Secondary Outcome Measures:
  • Measure the Acetylated Tubulin Expression and Correlate With Clinical Outcome. [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    IHC analysis of AT expression was performed in formalin-fixed, paraffin-embedded 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.


Enrollment: 14
Study Start Date: August 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel
Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.
Drug: Taxotere
Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.
Other Name: Docetaxel
Experimental: Cisplatin
Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.
Drug: Cisplatin
Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.
Experimental: 5-Fluorouracil
5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.
Drug: 5-fluorouracil
5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • WHO (World Health Organization)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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400205

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Sanofi
Investigators
Principal Investigator: Nabil Saba, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Nabil Saba, MD, Winship Cancer Institute
ClinicalTrials.gov Identifier: NCT00400205     History of Changes
Other Study ID Numbers: 0414-2006
Study First Received: November 15, 2006
Results First Received: December 6, 2010
Last Updated: March 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Squamous Cell Carcinoma of the Oral Cavity

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 18, 2014