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Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
This study has been completed.
Study NCT00006248   Information provided by National Cancer Institute (NCI)
First Received: September 11, 2000   Last Updated: July 23, 2008   History of Changes

September 11, 2000
July 23, 2008
November 2000
 
 
 
Complete list of historical versions of study NCT00006248 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
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.

OBJECTIVES:

  • Determine the overall survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with paclitaxel, cisplatin, and fluorouracil.
  • Determine response (unconfirmed, confirmed, complete, and partial) and time to treatment failure in patients with measurable disease treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 30 minutes on day 1 and fluorouracil IV over 24 hours on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 3 additional courses beyond CR.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 12 months.

Phase II
Interventional
Treatment
Head and Neck Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Drug: paclitaxel
 
Worden FP, Moon J, Samlowski W, Clark JI, Dakhil SR, Williamson S, Urba SG, Ensley J, Hussain MH; Southwest Oncology Group, Head and Neck Working Group. A phase II evaluation of a 3-hour infusion of paclitaxel, cisplatin, and 5-fluorouracil in patients with advanced or recurrent squamous cell carcinoma of the head and neck: Southwest Oncology Group study 0007. Cancer. 2006 Jul 15;107(2):319-27.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006248
 
CDR0000068180, SWOG-S0007
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Maha Hadi A. Hussain, MD University of Michigan Cancer Center
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP