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

December 3, 2013 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Joan H. Schiller, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1999

Study Registration Dates

First Submitted

January 28, 2000

First Submitted That Met QC Criteria

July 23, 2004

First Posted (Estimate)

July 26, 2004

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

August 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067524
  • WCCC-CO-98501
  • NCI-G00-1669

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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