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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.
Study NCT00003111   Information provided by Yale University
First Received: November 1, 1999   Last Updated: August 21, 2009   History of Changes

November 1, 1999
August 21, 2009
April 1997
 
 
 
Complete list of historical versions of study NCT00003111 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy Followed by Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC

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.

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.

Phase II
Interventional
Treatment
Lung Cancer
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: irinotecan hydrochloride
  • Drug: paclitaxel
  • Procedure: neoadjuvant therapy
  • Procedure: surgical procedure
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
10
April 2004
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003111
 
CDR0000065855, YALE-HIC-9317, NCI-G97-1345
Yale University
National Cancer Institute (NCI)
Study Chair: John R. Murren, MD Yale University
Yale University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP