Clinical trial NCT00625937: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: 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
tongue cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-02-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Objective response rate (complete or partial response) as assessed by RECIST criteria
Secondary outcomes:
measure: Progression-free survival
measure: Overall survival
measure: Toxicity as assessed by NCI CTCAE v3.0 criteria
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center at Yonsei University Medical Center
Study officials:
affiliation: Yonsei University
name: Joo-Hang Kim, MD
role: STUDY_CHAIR
References: