NCT00006248
S0007 - Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
PHASE2
COMPLETED
NCT00006248
INTERVENTIONAL
Evaluation of Three Hour Infusion of Paclitaxel Plus Cisplatin and 5-Fluorouracil in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent head and neck cancer.
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck
* Metastatic at diagnosis or persistent, metastatic, or recurrent after surgery and/or radiotherapy
* Relapse after prior induction or adjuvant therapy allowed
* No newly diagnosed nonmetastatic disease
* Measurable or nonmeasurable disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No grade 2 or greater sensory neuropathy
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent biologic therapy
Chemotherapy:
* See Disease Characteristics
* At least 6 months since prior carboplatin or cisplatin induction or adjuvant chemotherapy
* No more than 1 prior induction or adjuvant chemotherapy regimen
* No prior chemotherapy for recurrent or newly diagnosed metastatic disease
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent anticancer hormonal therapy
Radiotherapy:
* See Disease Characteristics
* At least 28 days since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* At least 28 days since prior surgery and recovered
Head and Neck Cancer
- TREATMENT
-
- Type: DRUG
- Name: cisplatin
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: fluorouracil
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: paclitaxel
- Description:
- Arm Group Labels:
- SWOG Cancer Research Network