Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

Detailed Description
-----------------
OBJECTIVES: Primary Determine the response rate in patients with previously treated persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and docetaxel. Secondary Determine the toxicity of this regimen in these patients. Determine the duration of response and survival of patients treated with this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 60 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses of therapy beyond documentation of CR. After completion of study treatment, patients are followed for survival. PROJECTED ACCRUAL: A total of 17-41 patients will be accrued within 42-49 months.

Official Title
-----------------
Phase II Study of Gemcitabine and Docetaxel (GEMDOC) Combination in Patients With Previously Treated Recurrent or Metatstatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: docetaxel
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck Metastatic, persistent, or recurrent disease Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Must have had definitive surgery and/or radiation therapy AND received at least 1, but no more than 2, chemotherapy regimens, either given as primary therapy or adjuvant therapy before or after surgery and/or radiotherapy No active or prior CNS metastasis PATIENT CHARACTERISTICS: Age 18 and over Performance status SWOG 0-2 Life expectancy At least 12 weeks Hematopoietic Granulocyte count > 1,500/mm^3 Hemoglobin ≥ 8 g/dL Platelet count > 100,000/mm^3 Hepatic Bilirubin normal Meets 1 of the following criteria: Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN AP ≤ 5 times ULN AND AST or ALT normal Renal Creatinine < 1.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment No peripheral neuropathy ≥ grade 2 No active infection requiring systemic therapy No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or any other site No history of severe hypersensitivity reaction to study drugs or other drugs formulated with polysorbate 80 No other serious condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior taxane or gemcitabine At least 4 weeks since prior chemotherapy and recovered Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered Surgery See Disease Characteristics Other No other concurrent therapy for this disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine, docetaxel<br>Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine. | Drug: docetaxel<br>* Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.<br>* Other names: Taxotere;Drug: Gemcitabine<br>* Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.<br>* Other names: Gemzar;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response (Complete Response [CR] + Partial Response [PR]) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | every 8 weeks for approximately 8 - 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Duration | Response duration in months | Every 8 weeks | 
| Survival | Overall Survival using the Kaplan-Meier method | Every 8 weeks | 
| Toxicity as Measured by Number and Grade of Adverse Events | Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event | Every 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity