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

This study has been completed.
Information provided by:
Yale University Identifier:
First received: March 7, 2000
Last updated: August 21, 2009
Last verified: August 2009

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 Intervention Phase
Lung Cancer
Drug: irinotecan hydrochloride
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Yale University:

Enrollment: 28
Study Start Date: March 1999
Study Completion Date: February 2006
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Study Chair: John R. Murren, MD Yale University
  More Information

Additional Information:
No publications provided Identifier: NCT00004924     History of Changes
Other Study ID Numbers: CDR0000067608, YALE-HIC-10740, NCI-G00-1701
Study First Received: March 7, 2000
Last Updated: August 21, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators processed this record on November 24, 2014