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Combination Chemotherapy Followed by Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University Identifier:
First received: November 1, 1999
Last updated: July 23, 2013
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: Phase II trial to study the effectiveness of combination chemotherapy with irinotecan and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer.

Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: cisplatin
Drug: irinotecan hydrochloride
Drug: paclitaxel
Procedure: neoadjuvant therapy
Procedure: surgical procedure
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC

Resource links provided by NLM:

Further study details as provided by Yale University:

Enrollment: 10
Study Start Date: April 1997
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Detailed Description:


  • Evaluate the efficacy of irinotecan based chemotherapy in patients with stage IIIA non-small cell lung cancer.
  • Investigate the phenotypic changes induced in the tumor by this treatment.

OUTLINE: Patients receive IV cisplatin over 30 minutes followed by IV irinotecan over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 3 courses until disease progression. Once potential candidates for resectability are determined, patients undergo thoracotomy or concurrent chemotherapy/radiation therapy within 6 weeks of completing the last course of chemotherapy. Following resection, patients responding to chemotherapy receive 3 additional courses of IV carboplatin and paclitaxel over 3 hours. Patients may undergo local irradiation beginning with the second course of carboplatin and paclitaxel. Chemotherapy ceases if disease remains stable after 8 weeks.

Patients are followed every 3 months for the first year after treatment, then every 6 months thereafter for survival.

PROJECTED ACCRUAL: This study will accrue 20 patients over 18 months.


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


  • Histologically confirmed, previously untreated stage IIIa (T1-2 N2 M0) non-small cell lung cancer



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


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


  • Total bilirubin no greater than 1.5 mg/dL


  • Creatinine clearance at least 55 mL/min


  • Not HIV positive
  • No active infections
  • Not pregnant or lactating
  • Effective contraception required of fertile patients during study participation
  • No coexisting medical condition


Biologic therapy:

  • Not specified


  • No prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiation therapy
  • No concurrent radiation therapy


  • Not specified


  • No concurrent use of investigational agents during study participation
  Contacts and Locations
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Please refer to this study by its identifier: NCT00003111

United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Study Chair: John R. Murren, MD Yale University
  More Information

Responsible Party: Yale University Identifier: NCT00003111     History of Changes
Other Study ID Numbers: CDR0000065855  YALE-HIC-9317  NCI-G97-1345 
Study First Received: November 1, 1999
Last Updated: July 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Yale University:
stage IIIA 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
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on October 27, 2016