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

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT00003111
Collaborator
National Cancer Institute (NCI) (NIH)
10
Enrollment
1
Location
84
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Primary Purpose:
Treatment
Official Title:
Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC
Study Start Date :
Apr 1, 1997
Actual Primary Completion Date :
Apr 1, 2004
Actual Study Completion Date :
Apr 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT00003111
    Other Study ID Numbers:
    • CDR0000065855
    • YALE-HIC-9317
    • NCI-G97-1345
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 25, 2013
    Last Verified:
    Aug 1, 2009
    Keywords provided by Yale University
    stage IIIA non-small cell lung cancer
    Additional relevant MeSH terms:
    Lung Neoplasms
    Paclitaxel
    Carboplatin
    Irinotecan

    Study Results

    No Results Posted as of Jul 25, 2013