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Phase II Study of 96 Hour Paclitaxel Infusion in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Paclitaxel in Treating Patients With Advanced Head and Neck Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Completed 18 and over NCI E-3395
NCT00002922, E3395

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.

Entry 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

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

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

Expected Enrollment

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

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.

Published Results

Langer CJ, Li Y, Jennings T, et al.: Phase II evaluation of 96-hour paclitaxel infusion in advanced (recurrent or metastatic) squamous cell carcinoma of the head and neck (E3395): a trial of the Eastern Cooperative Oncology Group. Cancer Invest 22 (6): 823-31, 2004.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Corey Langer, MD, Protocol chair
Ph: 215-728-2985; 888-369-2427
Email: cj_langer@fccc.edu

Registry Information

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

Trial Start Date		1997-01-07

Registered in ClinicalTrials.gov		NCT00002922

Date Submitted to PDQ		1997-01-07

Information Last Verified		2005-02-04

NCI Grant/Contract Number		CA21115

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.