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Phase II Evaluation of Paclitaxel Infusion in Advanced (Recurrent or Metastatic) Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Evaluation of Paclitaxel Infusion in Advanced (Recurrent or Metastatic) Squamous Cell Carcinoma of the Head and Neck


OBJECTIVES: I. Evaluate the response rate and toxic effects of paclitaxel by 96 hour
continuous infusion in chemotherapy naive and chemotherapy exposed patients with recurrent
or metastatic squamous cell carcinoma of the head and neck.

OUTLINE: Patients receive paclitaxel as a 96 hour continuous IV infusion. Courses repeat
every 3 weeks for a maximum of 12 courses. Patients with disease progression after 2 courses
or with unacceptable toxicity at any time are removed from study.

PROJECTED ACCRUAL: Approximately 109 patients will be accrued for this study over 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and
neck (including nasopharynx) that is considered incurable with surgery or radiation
therapy Bidimensionally measurable disease Patients whose only site of measurable disease
is within a previous radiation port must have documented progressive disease or
biopsy-proven recurrence after the completion of radiotherapy No uncontrolled CNS
metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic:
Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min Calcium normal No history of hypercalcemia
Cardiovascular: No history of ventricular arrhythmias or symptomatic bradyarrhythmia
Other: No significant detectable infection Not pregnant or nursing No other active
malignancies Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interleukin-2, interferons, and
monoclonal antibodies allowed Recovered from prior therapy Chemotherapy: Prior paclitaxel
infusion no greater than 24 hours for recurrent or metastatic disease required Endocrine
therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: Recovered
from any prior major surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065327

NCT ID:

NCT00002922

Start Date:

January 1997

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
University of Rochester Cancer CenterRochester, New York  14642
Ireland Cancer CenterCleveland, Ohio  44106-5065
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304