NCT00100789
S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
PHASE2
COMPLETED
NCT00100789
INTERVENTIONAL
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)
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.
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
Head and Neck Cancer
- TREATMENT
-
- Type: DRUG
- Name: gemcitabine
- Description: 3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).
- Arm Group Labels: gemcitabine paclitaxel combination
-
- Type: DRUG
- Name: paclitaxel
- Description: 150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine
- Arm Group Labels: gemcitabine paclitaxel combination
- SWOG Cancer Research Network