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Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

Primary Purpose

Squamous Cell Carcinoma, Oral Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Docetaxel

Cisplatin

5-fluorouracil

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring Squamous Cell Carcinoma of the Oral Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Emory University Winship Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recipients of Docetaxel, Cisplatin, 5-Fluorouracil

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Tumor Change by Baseline Acetylated Tubulin Expression Score

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.

Full Information

NCT ID

NCT00400205

First Posted

November 15, 2006

Last Updated

October 5, 2017

Sponsor

Emory University

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00400205

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Terminated

Why Stopped

Safety reasons

Study Start Date

August 2006 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma, Oral Cancer

Keywords

Squamous Cell Carcinoma of the Oral Cavity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Recipients of Docetaxel, Cisplatin, 5-Fluorouracil

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

5-fluorouracil

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

every 3 months

Secondary Outcome Measure Information:

Title

Tumor Change by Baseline Acetylated Tubulin Expression Score

Description

Time Frame

Baseline, After 3 cycles of study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nabil Saba, MD

Organizational Affiliation

Emory University Winship Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23881549

Citation

Saba NF, Magliocca KR, Kim S, Muller S, Chen Z, Owonikoko TK, Sarlis NJ, Eggers C, Phelan V, Grist WJ, Chen AY, Ramalingam SS, Chen ZG, Beitler JJ, Shin DM, Khuri FR, Marcus AI. Acetylated tubulin (AT) as a prognostic marker in squamous cell carcinoma of the head and neck. Head Neck Pathol. 2014 Mar;8(1):66-72. doi: 10.1007/s12105-013-0476-6. Epub 2013 Jul 24.

Results Reference

result

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Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

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