Full Text View
Tabular View
No Study Results Posted
Related Studies
Pemetrexed or Erlotinib as Second-Line Therapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2009
First Received: August 20, 2008   Last Updated: May 5, 2009   History of Changes
Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Southwest Oncology Group
National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00738881
  Purpose

RATIONALE: Pemetrexed and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed is more effective than erlotinib in treating advanced non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying pemetrexed to see how well it works compared with erlotinib when given as second-line therapy in treating patients with advanced non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: erlotinib hydrochloride
Drug: pemetrexed disodium
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Pemetrexed Pemetrexed disodium Erlotinib hydrochloride Erlotinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non- Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival, confirmed response rate, and adverse event profile based on epidermal growth factor receptor (EGFR)-FISH status (positive vs negative) [ Designated as safety issue: Yes ]
  • Progression-free survival, overall survival, confirmed response rate, and adverse event profile based on EGFR gene mutation status [ Designated as safety issue: Yes ]
  • Progression-free survival, overall survival, confirmed response rate, and adverse event profile based on EGFR expression as measured by immunohistochemistry (IHC) [ Designated as safety issue: Yes ]
  • Prognostic effect of EGFR copy number, EGFR expression, and EGFR mutation status on outcome [ Designated as safety issue: No ]

Estimated Enrollment: 1196
Study Start Date: October 2008
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: erlotinib hydrochloride
Given orally
Arm II: Experimental
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: pemetrexed disodium
Given IV

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer (NSCLC), either on initial diagnosis or at the time of disease recurrence/progression

    • Mixed histology allowed if all components are consistent with NSCLC
  • Recurrent or progressive disease
  • Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as ≥ 2.0 cm by conventional techniques or as ≥ 1.0 cm by spiral CT scan

    • Measurable disease must be outside of any previously irradiated treatment field(s) unless there is disease progression or recurrence within the irradiated field(s)
    • No nonmeasurable disease only, defined as any of the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
      • Single disease site in prior radiotherapy field
  • Tumor tissue samples must be available and adequate for epidermal growth factor receptor (EGFR) evaluation by FISH
  • Previously treated with only one cytotoxic chemotherapy regimen for advanced disease

    • Neoadjuvant/adjuvant cytotoxic chemotherapy administered < 12 months (from date chemotherapy was started) prior to study entry will be counted as one prior treatment
    • Neoadjuvant/adjuvant chemotherapy administered ≥ 12 months prior to study entry and use of targeted agents (e.g., monoclonal antibodies) will not be counted as one prior treatment
  • No symptomatic serosal effusion (≥ grade 2 dyspnea as measured by CTCAE v3.0) that is not amenable to drainage
  • No brain metastasis, unless the the following criteria are met:

    • Brain metastasis is stable and has been previously treated with either whole-brain radiotherapy or gamma-knife surgery
    • More than 14 days since prior steroid treatment

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Total bilirubin normal (ULN) OR direct bilirubin normal
  • AST and ALT ≤ 2.5 times ULN
  • INR ≤ 1.5
  • Creatinine clearance ≥ 45 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to take folic acid, vitamin B_12 supplementation, and dexamethasone
  • No known HIV positivity
  • No clinically significant infection
  • No impaired gastrointestinal (GI) function, inability to swallow pills in the absence of a feeding tube, or GI disease that may significantly alter absorption of oral medications (e.g., ulcerative disease, uncontrolled nausea and vomiting, malabsorption syndromes, or bowel obstruction)
  • No serious condition that, in the opinion of the investigator, would preclude the patient's ability to complete the study therapy or increase the risk for serious adverse events
  • No other invasive malignant solid tumor or hematologic malignancy, except for any of the following:

    • Prior carcinoma in situ, regardless of organ involvement, or nonmelanoma cutaneous carcinoma that was definitively treated ≥ 3 years ago with no subsequent evidence of recurrence
    • Other prior malignancy diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence

      • Prior breast cancer that was definitively treated > 5 years ago allowed provided patient is not receiving aromatase inhibitors
      • Prior low-grade (Gleason score ≤ 6) localized prostate cancer that was diagnosed < 3 years ago allowed

        • Concurrent medications to maintain disease remission allowed
  • No concurrent severe and/or uncontrolled medical condition, including any of the following:

    • Angina pectoris
    • Congestive heart failure within the past 3 months, unless ejection fraction > 40%
    • Myocardial infarction within the past 6 months
    • Cardiac arrhythmia
    • Diabetes mellitus
    • Hypertension
    • Any other severe underlying disease that, in the judgment of the investigator, would preclude study entry
  • No respiratory symptoms > CTCAE grade 1
  • No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior radiotherapy, except for alopecia
  • No prior radiotherapy to > 25% of bone marrow
  • No prior EGFR tyrosine kinase inhibitors or pemetrexed disodium
  • More than 3 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
  • More than 2 weeks since prior immunotherapy, gene therapy, or other biologic therapy
  • More than 2 weeks since prior limited-field radiotherapy (4 weeks for full-field radiotherapy)
  • More than 2 weeks since prior minor surgery*
  • More than 4 weeks since prior major surgery (i.e., laparotomy)* or open biopsy
  • More than 4 weeks since prior hormonal therapy
  • More than 4 weeks since prior and no other concurrent ancillary therapy considered investigational (i.e., utilized for a non-FDA-approved indication and in the context of a research investigation)
  • No aspirin dose ≥ 1.3 g/day for ≥ 10 days before, during, and for ≥ 10 days after treatment with pemetrexed disodium
  • No other concurrent chemotherapy, immunotherapy, hormonal therapy, or radiotherapy

    • Radiotherapy for symptom palliation (e.g., painful pre-existing bony metastasis) allowed
  • No other concurrent anticancer therapy
  • No concurrent major surgery
  • No concurrent antiretroviral therapy
  • No concurrent prophylactic colony-stimulating factors NOTE: *Insertion of a vascular access device is not considered major or minor surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738881

  Show 272 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Southwest Oncology Group
National Cancer Institute of Canada
Investigators
Study Chair: Alex A. Adjei, MD, PhD Roswell Park Cancer Institute
Study Chair: Martin J. Edelman, MD University of Maryland Greenebaum Cancer Center
Study Chair: David P. Carbone, MD, PhD Vanderbilt-Ingram Cancer Center
Study Chair: Fred R. Hirsch, MD, PhD University of Colorado at Denver and Health Sciences Center
Study Chair: Geoffrey Liu, MD Princess Margaret Hospital, Canada
  More Information

Additional Information:
No publications provided

Responsible Party: North Central Cancer Treatment Group ( Jan C. Buckner )
Study ID Numbers: CDR0000612010, NCCTG-N0723, CALGB-30802, CAN-NCIC-BRC4
Study First Received: August 20, 2008
Last Updated: May 5, 2009
ClinicalTrials.gov Identifier: NCT00738881     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:
Antimetabolites
Thoracic Neoplasms
Erlotinib
Folic Acid Antagonists
Protein Kinase Inhibitors
Recurrence
Carcinoma
Pemetrexed
Folic Acid
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Pemetrexed
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009