Overview

Paclitaxel in Treating Patients With Recurrent or Refractory Non-small Cell Lung Cancer

Status:
Unknown status
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 who have recurrent or refractory non-small cell lung cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Wisconsin, Madison
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer with
documented recurrent or refractory disease Progressive disease at more than 3 months from
completion of first line chemotherapy OR Progressive disease during first line chemotherapy
Clinically stable CNS metastases allowed

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not
specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic:
Bilirubin no greater than 2.0 mg/dL AST no greater than 5 times upper limit of normal
Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
Cardiovascular: No clinically significant bradyarrhythmias Other: Neuropathy less than
grade 2 Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy
Chemotherapy: See Disease Characteristics Must have had at least 1 prior first line
chemotherapy regimen for metastatic or locally advanced disease One prior paclitaxel
regimen (every 3 week schedule) allowed if no progressive disease at less than 3 months
from completion of therapy At least 4 weeks since prior chemotherapy Endocrine therapy: Not
specified Radiotherapy: At least 2 weeks since prior radiotherapy (indicator lesions within
the radiation port must have progressed since completion of therapy) Surgery: Not specified