Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
New Mexico Cancer Research Alliance
Study ID
NCT00391586
Phase
PHASE2
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Erlotinib will be administered for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or intolerance to erlotinib, standard of care platinum-based chemotherapy (per the choice of the treating physician) is administered every 3 weeks. Physicians can adjust dose, schedule, or supportive care to the benefit of the patient
  • Platinum-based chemotherapy — DRUG
    Intravenous chemotherapy combination per physician discretion every 3 weeks for at least 2 cycles

Study Details

This study was conducted to compare the activities of erlotinib to that of intravenous, platinum-based therapy in the treatment of non-small cell lung cancer (NSCLC). The goal of this trial was to demonstrate clinical equivalence of erlotinib to platinum-based frontline therapy, compared to historical controls.

Key Dates

First listed
Oct 24, 2006
Start date
Jul 31, 2006
Status verified
Aug 2015
Primary completion
May 31, 2011
Completion
May 31, 2012

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib followed by chemotherapy
    Erlotinib: 150 mg orally once daily, Platinum-based chemotherapy regimen selections include: Carboplatin (Carbo) area under the curve (AUC) 6, or cisplatin (Cis) 60-100 mg/m2, day (D)1, administered with one of the following: 1. Docetaxel 75 mg/m2, D1 2. Docetaxel 35 mg/m2, D1,8,15 3. Paclitaxel 200-225 mg/m2, D1 4. Paclitaxel 80-100 mg/m2, D1,8,15 Carbo AUC 5-6, or Cis 60-100 mg/m2, D1, administered with one of the following: 1. Etoposide 100 mg/m2 D1-3 2. Etoposide 200 mg/m2 orally D1-3 3. Pemetrexed 500 mg/m2, D 1 4. Irinotecan 50 mg/m2 D1,8,15 Other regimens: 1. Gemcitabine 1000 mg/m2-1250 mg/m2, D1,8 + Carbo AUC 6, or Cis 60-100 mg/m2, D1 or 8 2. Vinorelbine 25 mg/m2 D1,8 + Carbo AUC 5, or Cis 80 mg/m2 D1

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 5 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Hematology Oncology Associates NMAlbuquerqueNew Mexico87106-
Lovelace Medical GroupAlbuquerqueNew Mexico87102-
Presbyterian Medical GroupAlbuquerqueNew Mexico87110-
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87131-
New Mexico Cancer Care AssociatesSanta FeNew Mexico87505-

Find similar trials in Albuquerque, NM

By research site
Hematology Oncology Associates NM· Albuquerque, NMLovelace Medical Group· Albuquerque, NMPresbyterian Medical Group· Albuquerque, NMUniversity of New Mexico Cancer Center· Albuquerque, NMNew Mexico Cancer Care Associates· Santa Fe, NM

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