Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00042835
Phase
PHASE1
Status
Terminated

Conditions

  • Adenocarcinoma of the Lung
  • Bronchoalveolar Cell Lung Cancer
  • Large Cell Lung Cancer
  • Squamous Cell Lung Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • cisplatin — DRUG
    Given IV
  • etoposide — DRUG
    Given IV
  • erlotinib hydrochloride — DRUG
    Given orally
  • radiation therapy — RADIATION
    Undergo radiotherapy
  • docetaxel — DRUG
    Given IV
  • paclitaxel — DRUG
    Given IV
  • carboplatin — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and radiation therapy with combination chemotherapy may kill more tumor cells. Phase I trial to study the effectiveness of combining erlotinib and radiation therapy with combination chemotherapy in treating patients who have inoperable stage III non-small cell lung cancer

Key Dates

First listed
Jan 27, 2003
Start date
May 31, 2002
Status verified
Jan 2013
Primary completion
Dec 31, 2008

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (cisplatin, etoposide, erlotinib, and docetaxel)
    Patients receive cisplatin IV over 2 hours on days 1, 8, 29, and 36; etoposide IV over 1 hour on days 1-5 and 29-33; and oral erlotinib once daily on days 1-49. Patients undergo concurrent radiotherapy 5 days a week for 7 weeks beginning on day 1. Patients receive consolidation therapy comprising docetaxel IV over 1 hour on days 50, 71, and 92. Some patients may also receive oral erlotinib once daily on days 50-112.
  • Experimental: Group II (paclitaxel, carboplatin, and erlotinib
    Patients receive induction chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21. Patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 43, 50, 57, 64, 71, 78, and 85 and oral erlotinib once daily on days 43-91. Patients undergo radiotherapy concurrently with consolidation therapy 5 days a week for 7 weeks beginning on day 43.

Primary Outcome Measure

MTD defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0 [ Time Frame: 7 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-1470-

Find similar trials in Chicago, IL

By research site
University of Chicago Comprehensive Cancer Center· Chicago, IL

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