NCT00006248

S0007 - Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Official Title:

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)

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Head and Neck Cancer

Primary Purpose
  • TREATMENT
Intervention/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:
Sponsor
  • SWOG Cancer Research Network