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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)
Sexes Eligible for Study:   All
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
Study First Received: November 1, 1999
Last Updated: July 23, 2013

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
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 17, 2017