Paclitaxel in Treating Patients With Advanced Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00002922
First received: November 1, 1999
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or metastatic head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Evaluation of Paclitaxel Infusion in Advanced (Recurrent or Metastatic) Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Study Start Date: January 1997
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002922

  Hide Study Locations
Locations
United States, California
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Florida
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
United States, Illinois
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, United States, 60611
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Massachusetts
New England Medical Center Hospital
Boston, Massachusetts, United States, 02111
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
United States, New York
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
CCOP - Geisinger Clinical and Medical Center
Danville, Pennsylvania, United States, 17822-2001
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
South Africa
Pretoria Academic Hospital
Pretoria, South Africa, 0001
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002922     History of Changes
Other Study ID Numbers: CDR0000065327, E-3395
Study First Received: November 1, 1999
Last Updated: August 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014