Erlotinib, Paclitaxel, and Carboplatin Combined With Radiation Therapy for Stage III Non-Small Cell Lung Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Nathan Pennell, MD, PhD
Study ID
NCT00278148
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • carboplatin — DRUG
    AUC2 weekly x 3 weeks
  • Erlotinib — DRUG
    Daily
  • paclitaxel — DRUG
    50mg/m2/weekly x 3 weeks
  • conventional surgery — PROCEDURE
    conventional surgery
  • radiation therapy — RADIATION
    150 cGy bid

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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib, paclitaxel, and carboplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I/II trial is studying the best dose of erlotinib and the side effects of erlotinib, paclitaxel, and carboplatin when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Key Dates

First listed
Jan 18, 2006
Start date
Oct 31, 2005
Status verified
Jul 2020
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level A
    Erlotinib, Paclitaxel, and Carboplatin with Radiation Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
  • Experimental: Dose Level B
    Erlotinib, Paclitaxel, and Carboplatin with Radiation Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
  • Experimental: Dose Level C
    Erlotinib, Paclitaxel, and Carboplatin with Radiation Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin

Primary Outcome Measure

Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I) [ Time Frame: 2 weeks after surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OH

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