Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eastern Cooperative Oncology Group
With
National Cancer Institute (NCI)
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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Paclitaxel in Treating Patients With Advanced Head and Neck Cancer
