Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004924
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 25, 2009
National Cancer Institute (NCI)
Information provided by:
Yale University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: irinotecan hydrochloride Drug: paclitaxel Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Primary Purpose: Treatment
Official Title: Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer
Study Start Date : March 1999
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


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


  • 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)


  • Creatinine clearance at least 70 mL/min


  • 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


Biologic therapy:

  • Not specified


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

Endocrine therapy:

  • Not specified


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


  • See Disease Characteristics
  • Recovered from prior surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004924

United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
Northwestern Connecticut Oncology-Hematology Associates - Torrington
Torrington, Connecticut, United States, 06790
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Study Chair: John R. Murren, MD Yale University Identifier: NCT00004924     History of Changes
Other Study ID Numbers: CDR0000067608
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009

Keywords provided by Yale University:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors