S0329, Gemcitabine and Paclitaxel 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 paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

Detailed Description
-----------------
OBJECTIVES: Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel. Determine the confirmed and unconfirmed response (partial and complete) probability in patients with measurable disease treated with this regimen. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Patients are followed every 8 weeks until disease progression, every 6 month for 2 years, and then annually for 1 year. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 10-13 months.

Official Title
-----------------
A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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

Intervention / Treatment
-----------------
* Drug: gemcitabine
* Drug: paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) Recurrent, persistent, or newly diagnosed metastatic disease Measurable or non-measurable disease No active or prior CNS metastasis PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No serious organ dysfunction No serious comorbid conditions that would preclude study treatment No history of hypersensitivity reaction to products containing polysorbate 80 No active infection requiring systemic antibiotic therapy No symptomatic sensory neuropathy ≥ grade 2 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 Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic or immunotherapy for SCCHN No concurrent gene therapy for SCCHN Chemotherapy No prior chemotherapy for recurrent or newly diagnosed metastatic disease At least 6 months since prior induction or adjuvant chemotherapy No more than 1 prior induction or adjuvant regimen No prior gemcitabine or taxanes as part of induction, adjuvant, or neoadjuvant chemotherapy No other concurrent chemotherapy for SCCHN Endocrine therapy Not specified Radiotherapy At least 28 days since prior radiotherapy and recovered No concurrent radiotherapy for SCCHN Surgery Not specified Other No other concurrent therapy for SCCHN

Ages Eligible for Study
-----------------
Minimum Age: 18 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 paclitaxel combination<br> | Drug: gemcitabine<br>* 3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).<br>* Other names: NSC-613327;Drug: paclitaxel<br>* 150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine<br>* Other names: NSC-673089;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. | 0 - 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. | 0 - 3 years | 
| Response | Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. | 9 weeks - 3 years | 
| Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. | Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lip, Recurrent, stage IV, squamous cell carcinoma, hypopharynx, larynx, oral cavity, nasopharynx, oropharynx, paranasal, nasal cavity, metastatic, neck cancer