Paclitaxel in Treating Patients With Advanced Head and Neck Cancer

June 15, 2023 updated by: Eastern Cooperative Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

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

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

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

Description

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

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

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Corey J. Langer, MD, Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 21, 1997

Primary Completion (Actual)

September 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 6, 2004

First Posted (Estimated)

July 7, 2004

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065327
  • E-3395

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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