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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00391586
First received: October 23, 2006
Last updated: October 19, 2012
Last verified: May 2012
  Purpose

Primary Objective:To compare the activities of erlotinib to that of platinum-based therapy in NSCLC


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Erlotinib
Drug: Intravenous chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: INST 0601C: A Randomized Phase II Protocol of Erlotinib Versus Standard Platinum-Based Chemotherapy in Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Objective tumor response, clinical benefit, tumor responses + stable disease [ Time Frame: disease progress or complete remission ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To document the rate of response, median duration of response, and median overall survivals of subjects as a function of the treatment administered [ Time Frame: disease progression, unacceptable toxicities ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: July 2006
Study Completion Date: May 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib
Erlotinib -- 150 mg tablet QD
Drug: Erlotinib
Erlotinib will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single-agent Tarceva, 150 mg/day.
Other Name: Tarceva
Drug: Erlotinib
Erlotinib -- 150 mg tablet QD
Other Names:
  • Randomized Erlotinib Arm for possibly 6 cycles but at least 2 cycles.
  • Each cycle = 21 days.
  • Erlotinib = 150 mg PO QD.
  • After 6 cycles SOC platinum-based chemotherapy will be given to patients
  • based on individual response and physician discretion.
  • If disease progression occurs, SOC platinum-based chemotherapy is initiated.
Active Comparator: 2
IV Chemotherapy Regime Combination per Physician discretion Q3Weeks
Drug: Intravenous chemotherapy
IV Chemotherapy Regime Combination per Physician discretion Q3Weeks

Detailed Description:

Primary Objective:To compare the activities(the progression-free survival, and the incidence and severity of toxicities, and reversibility of toxicities) of erlotinib to that of platinum-based therapy in NSCLC

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior chemotherapy will be allowed for other invasive malignancies, provided at least five years has elapsed since the completion of therapy and enrollment on this protocol. No prior chemotherapy for metastatic NSCLC will be allowed. Prior adjuvant or neoadjuvant chemotherapy for NSCLC will be allowed, provided at least six months have elapsed from the last dose of chemotherapy to the documentation of relapsed disease.

Baseline laboratory values (bone marrow, renal, hepatic):

  • Adequate bone marrow function:

    • Absolute neutrophil count >1000/µL
    • Platelet count >100'000/µL
  • Renal function:

    • Serum creatinine < 2.0 mg %
  • Hepatic function:

    • Bilirubin <1.5x normal
    • Serum calcium < 12 mg/dl

Other Eligibility Criteria:

  • Signed Informed Consent
  • ECOG/Zubrod/SWOG Performance Status <2 (Karnofsky Performance Status > 70%)
  • Life expectancy > 8 weeks
  • Male or female' age >18 years
  • Patients of childbearing potential must be using an effective means of contraception.
  • Histologic diagnosis of NSCLC that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic disease

Exclusion Criteria:

  • Prior therapy with an epidermal growth factor receptor inhibitor, including erlotinib, gefitinib, and cetuximab, as well as any investigational HER-1 inhibiting agent
  • Pregnant or lactating females
  • Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0
  • Uncontrolled' clinically significant dysrhythmia
  • History of prior malignancy within the prior five years, with the exception of non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix
  • Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
  • Uncontrolled metastatic disease of the central nervous system (previously treated, stable disease is allowable on this protocol)
  • Radiotherapy within the 2 weeks before Cycle 1' Day 1
  • Surgery within the 2 weeks before Cycle 1' Day 1
  • Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391586

Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
Hematology Oncology Associates NM
Albuquerque, New Mexico, United States, 87106
Lovelace Medical Group
Albuquerque, New Mexico, United States, 87102
Presbyterian Medical Group
Albuquerque, New Mexico, United States, 87110
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Genentech
Investigators
Principal Investigator: Dennie V Jones, MD University of New Mexico
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00391586     History of Changes
Other Study ID Numbers: INST 0601C
Study First Received: October 23, 2006
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
erlotinib
NSCLC
chemotherapy
platinum
lung
lung cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014