Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer

July 23, 2008 updated by: Theradex

A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer

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 refractory head and neck cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the objective response rate of paclitaxel as salvage therapy in patients with recurrent or refractory head and neck cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life in these patients.

OUTLINE: This is an open label, multicenter, nonrandomized study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects are observed. Patients are followed every 2 months for the first year, then every 4 months until completion of treatment, and then every 3 months until death. Patients complete a quality of life questionnaire prior to each of the first 6 courses, then every 2 courses thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93720
        • California Cancer Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Cancer Center at Memorial Regional Hospital
      • Miami, Florida, United States, 33136
        • Sylvester Cancer Center, University of Miami
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Savannah Hematology Oncology Associates
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital Cancer Care Institute
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine and Blood Disorders
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Johns Hopkins Oncology Center
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Kansas City Internal Medicine
    • New York
      • Binghamton, New York, United States, 13905
        • Lourdes Regional Cancer Center
      • New York, New York, United States, 10011
        • Saint Vincent Catholic Medical Center of New York
    • North Carolina
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Healthcare
    • Ohio
      • Akron, Ohio, United States, 44309
        • Akron City Hospital
      • Dayton, Ohio, United States, 45409
        • Medical Oncology Hematology Associates, Inc.
    • Pennsylvania
      • Reading, Pennsylvania, United States, 19612-6052
        • Reading Hospital and Medical Center
    • Texas
      • Lubbock, Texas, United States, 79410-1894
        • Joe Arrington Cancer Research and Treatment Center
      • San Antonio, Texas, United States, 78229
        • Cancer Care Institute of South Texas
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Hematology and Oncology, Inc.
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory head and neck cancer Measurable or evaluable disease At least one prior chemotherapy regimen for recurrent or metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN Calcium within normal limits Cardiovascular: No New York Heart Association class III-IV heart disease No myocardial infarction within 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusions or arrhythmias Neurologic: No peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing Fertile patients must use effective contraceptive method Negative pregnancy test No active infection or serious underlying medical condition No history of hypersensitivity to drugs containing Cremophor (teniposide, cyclosporine, or vitamin K) No prior invasive malignancies within the past 2 years, except: Curatively treated basal or squamous cell carcinoma of the skin Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 5 weeks since prior nitrosoureas, melphalan, or mitomycin At least 3 weeks since other prior chemotherapy Prior taxane therapy allowed only if administered on a 3 week or greater schedule No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy Concurrent megestrol (Megace) allowed No other concurrent hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to greater than 30% of bone marrow No concurrent radiotherapy Surgery: At least 3 weeks since major surgery Other: At least 1 week since prior parenteral antibiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theradex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1997

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 19, 2004

First Posted (Estimate)

March 22, 2004

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

November 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066279
  • THERADEX-B97-5250
  • BMS-TAX/MEN.05
  • NCI-V98-1415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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