Paclitaxel in Treating Patients With Advanced Head and Neck Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on 2007-02-20
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Squamous Cell Carcinoma of the Hypopharynx; Squamous Cell Carcinoma of the Larynx; Squamous Cell Carcinoma of the Lip and Oral Cavity; Squamous Cell Carcinoma of the Nasopharynx; Squamous Cell Carcinoma of the Oropharynx; Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Intervention: cimetidine (Drug); dexamethasone (Drug); diphenhydramine hydrochloride (Drug); filgrastim (Drug); paclitaxel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
Corey Jay Langer, Study Chair, Affiliation: Eastern Cooperative Oncology Group
Summary
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.
Clinical Details
Official title:
Phase II Study of 96 Hour Paclitaxel Infusion in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study design: Interventional, 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.
PROTOCOL 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
Minimum age: 18 Years.
Criteria:
PROTOCOL 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
Locations and Contacts
Stanford University Medical Center, Stanford, California 94305-5408, United States
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California 94304, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States
Sylvester Cancer Center, University of Miami, Miami, Florida 33136, United States
Emory University Hospital - Atlanta, Atlanta, Georgia 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia 30033, United States
Pretoria Academic Hospital, Pretoria 0001, South Africa
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611, United States
Veterans Affairs Medical Center - Chicago (Lakeside), Chicago, Illinois 60611, United States
New England Medical Center Hospital, Boston, Massachusetts 02111, United States
CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey 07018-1095, United States
University of Rochester Cancer Center, Rochester, New York 14642, United States
CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States
Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States
CCOP - Geisinger Clinical and Medical Center, Danville, Pennsylvania 17822-2001, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin 53295, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date:
January 1997
Last updated: January 11, 2007
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