Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

Part of paid clinical trials in Greenbrae, California.

Sponsor
OSI Pharmaceuticals
Study ID
NCT00085839
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tarceva (Trademark) (erlotinib HCl, OSI-774) — DRUG
    Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
  • Combination carboplatin and paclitaxel — DRUG
    Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Study Details

The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

Key Dates

First listed
Jun 17, 2004
Start date
Feb 29, 2004
Status verified
Aug 2012
Primary completion
Mar 31, 2007
Completion
Mar 31, 2007

Study Design

Enrollment
103 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
  • Active Comparator: Standard Chemotherapy
    Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Primary Outcome Measure

Progression-free Survival [ Time Frame: Until time of disease progression (maximum 5 months) ]

Locations (19)

FacilityCityStateZIPSite coordinators
California Cancer Care, Inc.GreenbraeCalifornia94904-
Sharp Clinical Oncology ResearchSan DiegoCalifornia92123-
Holy Cross HospitalFort LauderdaleFlorida33308-
University of MiamiMiamiFlorida33136-
Mount Sinai Cancer CenterMiami BeachFlorida33140-
Evanston Northwestern HealthcareEvanstonIllinois60201-
Oncology/Hematology Associates of Central IllinoisPeoriaIllinois61615-
Norton Healthcare, Inc.LouisvilleKentucky40202-
Maryland Hematology/Oncology AssociatesBaltimoreMaryland21237-
VA Sierra Nevada Health Care SystemRenoNevada89502-
Weill Medical College of Cornell UniversityNew YorkNew York10021-
FEK Addo, PCBismarckNorth Dakota58503-
Gabrail Cancer CenterCantonOhio44718-
University Hospitals of ClevelandClevelandOhio44106-
Ohio State UniversityColumbusOhio43210-1240-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Charleston Hematology OncologyCharlestonSouth Carolina29403-
East Tennessee Oncology/Hematology, PCKnoxvilleTennessee37920-
Sarah Cannon Cancer CenterNashvilleTennessee37203-

Find similar trials in Greenbrae, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
California Cancer Care, Inc.· Greenbrae, CASharp Clinical Oncology Research· San Diego, CAHoly Cross Hospital· Fort Lauderdale, FLUniversity of Miami· Miami, FLMount Sinai Cancer Center· Miami Beach, FLEvanston Northwestern Healthcare· Evanston, IL

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