Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT00287989
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with paclitaxel and carboplatin may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different doses of erlotinib when given together with paclitaxel and carboplatin to compare how well they work in treating patients with stage III, stage IV, or recurrent non-small cell lung cancer.

Key Dates

First listed
Feb 7, 2006
Start date
Nov 30, 2004
Status verified
Nov 2018
Primary completion
Aug 31, 2007
Completion
May 31, 2009

Study Design

Enrollment
86 participants (actual)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Arms

  • Experimental: 150 PRE
    Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
  • Experimental: 1,500 PRE
    Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
  • Experimental: 1,500 POST
    Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.

Primary Outcome Measure

Overall Response Rate [ Time Frame: after 6 cycles of chemotherapy ]

Locations (2)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-2410-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10021-

Find similar trials in Baltimore, MD

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MDMemorial Sloan-Kettering Cancer Center· New York, NY

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