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Status:

COMPLETED

Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ...

Detailed Description

OBJECTIVES: Primary * Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung Canc...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Pathologically proven non-small cell lung cancer (NSCLC)
  • Stage IA-IIIB disease
  • Underwent prior complete surgical resection (R0) no more than 2 months ago
  • Eligible for cisplatin-based adjuvant chemotherapy
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status ≥ 70%
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm\^3
  • Creatinine clearance \> 55 mL/min
  • Total bilirubin normal
  • Alkaline phosphatase, AST, and ALT must meet 1 of the following criteria:
  • Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
  • AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST and ALT normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No peripheral neuropathy \> grade 1
  • No hearing deficit at baseline, even if it does not require a hearing aid or intervention or interfere with activities of daily life (i.e., CTCAE grade 2 or higher)
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior postoperative radiation therapy
  • No prior chemotherapy for NSCLC
  • No prior docetaxel or cisplatin
  • No concurrent prophylactic filgrastim (G-CSF) or pegfilgrastim

Exclusion

    Key Trial Info

    Start Date :

    August 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 1 2009

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00281970

    Start Date

    August 1 2004

    End Date

    June 1 2009

    Last Update

    January 17 2019

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231-2410

    2

    Memorial Sloan-Kettering Cancer Center

    New York, New York, United States, 10021

    3

    Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, United States, 37232-6307