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Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
This study has been completed.
Study NCT00004924   Information provided by Yale University
First Received: March 7, 2000   Last Updated: August 21, 2009   History of Changes

March 7, 2000
August 21, 2009
March 1999
 
 
 
Complete list of historical versions of study NCT00004924 on ClinicalTrials.gov Archive Site
 
 
 
Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with irinotecan works in treating patients with advanced non-small cell lung cancer.

OBJECTIVES:

  • Determine the antitumor activity and toxicities of irinotecan and paclitaxel in patients with advanced non-small cell lung cancer.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes. Treatment continues weekly for 2 weeks followed by one week of rest. Courses are repeated every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study over 12 months.

Phase II
Interventional
Treatment
Lung Cancer
  • Drug: irinotecan hydrochloride
  • Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
28
February 2006
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic non-small cell lung cancer for which no curative therapy exists
  • Stage IIIB with pleural effusion allowed
  • Measurable or evaluable disease
  • CNS metastases allowed if disease stable at least 4 weeks following completion of surgery and/or radiotherapy and no anticonvulsant required

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if tumor involves liver)

Renal:

  • Creatinine clearance at least 70 mL/min

Other:

  • No other malignancies within past 3 years except nonmelanomatous skin cancer and carcinoma in situ of the cervix
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective birth control
  • No active infection
  • No concurrent medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy for lung cancer
  • No prior irinotecan or paclitaxel

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior wide field radiotherapy
  • No prior radiotherapy to greater than 20% of bone marrow allowed

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004924
 
CDR0000067608, YALE-HIC-10740, NCI-G00-1701
Yale University
National Cancer Institute (NCI)
Study Chair: John R. Murren, MD Yale University
Yale University
August 2009

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