Overview

Paclitaxel in Treating Patients With Advanced Head and Neck Cancer

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborator:

National Cancer Institute (NCI)

Treatments:

Albumin-Bound Paclitaxel
Paclitaxel

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