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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003111
First Posted: January 27, 2003
Last Update Posted: July 25, 2013
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University
  Purpose

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:

OBJECTIVES:

  • 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.

  Eligibility

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
Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Total bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine clearance at least 55 mL/min

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiation therapy
  • No concurrent radiation therapy

Surgery:

  • Not specified

Other:

  • No concurrent use of investigational agents during study participation
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00003111


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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00003111     History of Changes
Other Study ID Numbers: CDR0000065855
YALE-HIC-9317
NCI-G97-1345
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: July 25, 2013
Last Verified: August 2009

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
Cisplatin
Carboplatin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action