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Gemcitabine and/or Erlotinib as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00283244
First received: January 24, 2006
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether gemcitabine and erlotinib are more effective when given alone or together in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how well they work when given alone or together as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
 Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
 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: Randomized Phase II Study of First-Line Treatment With Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant


Secondary Outcome Measures:
  • Response rate [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    The best overall response is the best response recorded from the start of the treatment until disease progression-recurrence (taking as reference for progressive disease the smallest measurement recorded since the treatment started.

  • Overall survival rate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    For this study, the surveillance period is 6 weeks after completion of the combined modality portion of the protocol (induction plus concurrent chemotherapy and TCRT for dose escalation purposes but indefinitely for safety purposes

  • Toxicity [ Time Frame: After each cycle/3 weeks ] [ Designated as safety issue: Yes ]
    Assessments for treatment toxicity will e done with each cycle

  • Quality of life [ Time Frame: After each cycle/3 weeks ] [ Designated as safety issue: Yes ]
    FACT-L will be given to subjects after eacy cycle/3 weeks of treatment and after completion of treatment


Enrollment: 160
Study Start Date: March 2006
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive gemcitabine hydrochloride IV on days 1 and 8. Patients with progressive disease may cross over to arm II.
 Drug: gemcitabine hydrochloride
given IV
Experimental: Arm II
Patients receive oral erlotinib hydrochloride daily on days 1-21.
 Drug: erlotinib hydrochloride
given orally
Experimental: Arm III
Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride as in arm II.
 Drug: erlotinib hydrochloride
given orally
Drug: gemcitabine hydrochloride
given IV

Detailed Description:

OBJECTIVES:

Primary

  • Compare the progression-free survival rate of older patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride vs erlotinib hydrochloride vs gemcitabine hydrochloride and erlotinib hydrochloride as first-line therapy.

Secondary

  • Determine the response rate in patients receiving these regimens.
  • Determine the overall survival rate in patients receiving these regimens.
  • Determine the toxicity profile of these regimens in these patients.
  • Determine the quality of life of patients receiving these regimens.

OUTLINE: This is a randomized, open-label, controlled, parallel group, multicenter study. Patients are stratified by gender, smoking status (never or light vs current or former), and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV on days 1 and 8. Patients with progressive disease may cross over to arm II.
  • Arm II: Patients receive oral erlotinib hydrochloride daily on days 1-21.
  • Arm III: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride as in arm II.

In all arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months for 3 years.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Stage IIIB or IV disease
  • Measurable disease by RECIST criteria
  • Treated brain metastases allowed provided patient is asymptomatic

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 4 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Bilirubin normal
  • No history of severe hypersensitivity to gemcitabine hydrochloride
  • No severe comorbid illness
  • Able to participate in quality of life assessments

PRIOR CONCURRENT THERAPY:

  • Recovered from prior oncologic or other major surgery

  • One prior treatment for NSCLC allowed provided it was in the neoadjuvant or adjuvant setting

    • At least 1 year since prior treatment in the neoadjuvant or adjuvant setting
  • No other concurrent antineoplastic or antitumor agents or therapies, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283244

Locations
United States, Arkansas
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States, 72703
United States, Georgia
Summit Cancer Care
Savannah, Georgia, United States, 31405
United States, Illinois
Evanston Hospital
Evanston, Illinois, United States, 60201-1781
United States, New Jersey
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
Cape Fear Valley Medical Center Cancer Center
Fayetteville, North Carolina, United States, 28302-2000
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States, 27607
United States, Tennessee
Kingsport Hematology-Oncology Associates
Kingsport, Tennessee, United States, 37660
University of Tennessee Cancer Institute - Memphis
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas E Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00283244     History of Changes
Other Study ID Numbers: LCCC 0512, P30CA016086, UNC-LCCC-0512
Study First Received: January 24, 2006
Last Updated: March 30, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Erlotinib
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013