ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

This study has been completed.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006248
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: paclitaxel
Phase II

MedlinePlus related topics:   Cancer    Head and Neck Cancer   

Drug Information available for:   Cisplatin    Paclitaxel    Fluorouracil    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
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)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   November 2000

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006248

Show 95 study locations  Show 95 Study Locations

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Maha Hadi A. Hussain, MD     University of Michigan Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068180, SWOG-S0007
First Received:   September 11, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006248
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV squamous cell carcinoma of the lip and oral cavity  
recurrent squamous cell carcinoma of the lip and oral cavity  
stage IV squamous cell carcinoma of the oropharynx  
recurrent squamous cell carcinoma of the oropharynx  
stage IV squamous cell carcinoma of the nasopharynx  
recurrent squamous cell carcinoma of the nasopharynx  
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Study placed in the following topic categories:
Squamous cell carcinoma
Salicylsalicylic acid
Sodium Salicylate
Recurrence
Carcinoma
Epidermoid carcinoma
Nasopharyngeal carcinoma
Cisplatin
Paclitaxel
Fluorouracil
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers