Pemetrexed or Erlotinib as Second-Line Therapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

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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), February 2009
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 disodium Pemetrexed Erlotinib Erlotinib hydrochloride
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 &#8805; 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 (&#8805; 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 &#8805; 12 weeks
ANC &#8805; 1,500/mm^3
Platelet count &#8805; 100,000/mm^3
Hemoglobin &#8805; 10 g/dL
Total bilirubin normal (ULN) OR direct bilirubin normal
AST and ALT &#8804; 2.5 times ULN
PT/INR &#8804; 1.5
Creatinine clearance &#8805; 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 &#8805; 3 years ago with no subsequent evidence of recurrence
Other prior malignancy diagnosed and definitively treated &#8805; 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 &#8804; 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 &#8805; 1.3 g/day for &#8805; 10 days before, during, and for &#8805; 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 221 Study Locations

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
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


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000612010, NCCTG-N0723, CALGB-30802, CAN-NCIC-BRC4
Study First Received: August 20, 2008
Last Updated: February 5, 2009
ClinicalTrials.gov Identifier: NCT00738881 [history]
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:
Folic Acid
Erlotinib
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Protein Kinase Inhibitors
Pharmacologic Actions
Therapeutic Uses



ClinicalTrials.gov processed this record on February 10, 2009


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