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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2000 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00004265

First received: January 28, 2000

Last updated: July 23, 2008

Last verified: August 2000

History of Changes

Tracking Information

First Received Date ^ICMJE

January 28, 2000

Last Updated Date

July 23, 2008

Start Date ^ICMJE

February 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00004265 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Drug: paclitaxel

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00004265

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Joan H. Schiller, MD

University of Wisconsin, Madison

Information Provided By

National Cancer Institute (NCI)

Verification Date

August 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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