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Pemetrexed Disodium With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Responded to Previous Erlotinib
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00660816
  Purpose

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, 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 giving pemetrexed disodium together with erlotinib is more effective than giving pemetrexed disodium alone in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying pemetrexed disodium and erlotinib to see how well they work compared with pemetrexed disodium alone in treating patients with stage IIIB or stage IV non-small cell lung cancer that responded to previous erlotinib.


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

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: Randomized Phase II Trial, Comparing Pemetrexed Disodium Plus Erlotinib to Pemetrexed Disodium Alone in EGFR TKI-Responsive Non-Small Cell Lung Cancer

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 [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Disease stabilization rate (e.g., complete response, partial response, and stable disease) [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: January 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Active Comparator
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Drug: pemetrexed disodium
Given IV
Arm II: Experimental
Patients receive pemetrexed disodium IV over 10 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-19. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 8 courses may continue to receive oral erlotinib hydrochloride alone once daily in the absence of disease progression or unacceptable toxicity.
Drug: erlotinib hydrochloride
Given orally
Drug: pemetrexed disodium
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • To compare the progression-free survival of patients with erlotinib hydrochloride-responsive stage IIIB or IV non-small cell lung cancer treated with pemetrexed disodium with vs without erlotinib hydrochloride.

Secondary

  • To compare the response rate in patients treated with these regimens.
  • To compare the overall survival of patients treated with these regimens.
  • To compare the disease stabilization rate (e.g., complete response, partial response, and stable disease) in patients treated with these regimens.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to lifetime smoking status (never vs ever) and ECOG performance status (0-1 vs ≥ 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive pemetrexed disodium IV over 10 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-19. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 8 courses may continue to receive oral erlotinib hydrochloride alone once daily in the absence of disease progression or unacceptable toxicity.

Patients complete a smoking status survey at baseline and then every 3 months thereafter.

After completion of study treatment, patients are followed at approximately 30 days.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Pathologically confirmed non-small cell lung cancer

    • Stage IIIB (with pleural effusion) or IV disease
  • Progressive disease after ≥ 12 weeks of treatment with single-agent erlotinib hydrochloride during which time the patient experienced a clinical benefit as assessed by the treating physician and by radiography (e.g., ≥ 1 CT scan demonstrating stable disease or response after ≥ 4 weeks of treatment with erlotinib hydrochloride monotherapy)
  • At least 1 measurable lesion
  • Baseline diagnostic tumor specimen available for correlative studies

    • Any diagnostic material is acceptable (e.g., paraffin block, cell block, fine-needle aspirate, etc.)
  • No third space fluid that cannot be controlled by drainage
  • No active CNS metastases as indicated by clinical symptoms, cerebral edema, or progressive growth

    • Patients with a clinical history of CNS metastases or cord compression are eligible provided they have been definitively treated and are clinically stable for ≥ 4 weeks before the first dose of study treatment if treated with prior whole brain radiotherapy (2 weeks if treated with prior gamma knife therapy)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 45 mL/min
  • Total bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN
  • Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Able to take folic acid, vitamin B12, and dexamethasone as per study guidelines
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for study entry

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 2 weeks since prior erlotinib hydrochloride
  • At least 3 weeks since prior major surgery, chemotherapy, radiotherapy, investigational agents, or other cancer therapy
  • No prior pemetrexed disodium
  • No prior EGFR therapy except erlotinib hydrochloride
  • No more than 1 prior cytotoxic chemotherapy regimen for relapsed or metastatic disease

    • Erlotinib hydrochloride is not considered a cytotoxic chemotherapy regimen
  • No NSAIDs or salicylates for 2 days before (5 days for long-acting NSAIDs [e.g., naproxen, piroxicam, diflunisal, or nabumetone]), during, and for 2 days after administration of pemetrexed disodium
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660816

Locations
United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center     800-641-2422        
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
Geauga Regional Hospital Recruiting
Cleveland, Ohio, United States, 44024
Contact: Balazs Halmos     216-368-3362        
Lake/University Ireland Cancer Center Recruiting
Cleveland, Ohio, United States, 44060
Contact: Balazs Halmos     216-368-3362        
University Suburban Health Center Recruiting
Cleveland, Ohio, United States, 44121
Contact: Balazs Halmos     216-368-3362        
Southwest General Health Center Recruiting
Cleveland, Ohio, United States, 44130
Contact: Balazs Halmos     216-368-3362        
UHHS Chagrin Highlands Medical Center Recruiting
Cleveland, Ohio, United States, 44122
Contact: Balazs Halmos     216-368-3362        
UHHS Westlake Medical Center Recruiting
Cleveland, Ohio, United States, 44145
Contact: Balazs Halmos     216-368-3362        
Mercy Cancer Center at Mercy Medical Center Recruiting
Cleveland, Ohio, United States, 44708
Contact: Balazs Halmos     216-368-3362        
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Balazs Halmos, MD Ireland Cancer Center
  More Information

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

Responsible Party: Ireland Cancer Center at University Hospitals/Case Medical Center ( Balazs Halmos )
Study ID Numbers: CDR0000593995, CASE-2507
Study First Received: April 16, 2008
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00660816  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent 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:
Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009