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Phase II Study of Weekly Paclitaxel as Second-Line Therapy in Patients With Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Phase II Study of Weekly Paclitaxel as Second-Line Therapy in Patients With Non-Small Cell Lung Cancer

OBJECTIVES: I. Determine the response rate and response duration in patients with recurrent
or refractory non-small cell lung cancer (NSCLC) treated with second line paclitaxel. II.
Determine the qualitative and quantitative toxicities of this treatment regimen in relapsed
patients with recurrent NSCLC. III. Evaluate the time to treatment failure and overall
survival in this patient population.

OUTLINE: Patients receive paclitaxel IV over 1 hour weekly for 6 weeks. Courses repeat every
8 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 30-60 patients will be accrued for this study.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Joan H. Schiller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

February 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792