Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer - Full Text View

Sponsored by:	Yonsei University
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00625937

Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with radiation therapy and low-dose cisplatin works in treating patients with stage III or stage IV head and neck cancer.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: S-1 Drug: cisplatin Drug: docetaxel Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Docetaxel Cisplatin S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-Dose Daily Cisplatin in Locally Advanced Head and Neck Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Objective response rate (complete or partial response) as assessed by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Toxicity as assessed by NCI CTCAE v3.0 criteria [ Designated as safety issue: Yes ]

Estimated Enrollment:	46
Study Start Date:	November 2006
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To assess the response rate in patients with stage III or IV head and neck cancer treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy and low-dose cisplatin.

Secondary

To assess the effect of this regimen on survival and locoregional and systemic control rates in these patients.

OUTLINE:

Induction chemotherapy: Patients receive oral S-1 twice daily on days 1-14 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Chemoradiotherapy: Patients receive low-dose cisplatin IV once daily and undergo radiotherapy 5 days a week for 7 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 18 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes:
- Squamous cell carcinoma
- Poorly differentiated carcinoma
- Lymphoepithelioma
Locally advanced disease (stage III or IV [M0] disease)
At least 1 unidimensionally measurable index lesion

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
Alkaline phosphatase ≤ 3.0 times ULN
AST and ALT ≤ 3.0 times ULN
Creatinine ≤ 1.5 times ULN
No concurrent serious systemic disorder that, in the opinion of investigator, would compromise the patient's ability to complete the study
No serious cardiac condition, including any of the following:
- Myocardial infarction within the past 6 months
- Angina
- NYHA class III-IV heart disease
No active infection requiring IV antibiotics, including active tuberculosis or HIV
No other malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
Able to comply with protocol or study procedures

PRIOR CONCURRENT THERAPY:

No prior radiotherapy or chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625937

Locations

Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center	Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Joo-Hang Kim, MD 82-2-2228-8131 kjhang@yuhs.ac

Sponsors and Collaborators

Yonsei University

Investigators

Study Chair:

Joo-Hang Kim, MD

Yonsei University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000582621, YONSEI-4-2006-021-0
Study First Received:	February 28, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00625937
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage III lymphoepithelioma of the nasopharynx

stage III squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx

Study placed in the following topic categories:

Docetaxel
Epidermoid carcinoma
Nasopharyngeal carcinoma
Cisplatin
Squamous cell carcinoma

Head and Neck Neoplasms
Carcinoma, squamous cell
Hypopharyngeal cancer
Carcinoma, Squamous Cell
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009