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Pharmacodynamic Separation of Pemetrexed and Erlotinib as Second-line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT00950365
Recruitment Status : Unknown
Verified July 2009 by Montefiore Medical Center.
Recruitment status was:  Recruiting
First Posted : July 31, 2009
Last Update Posted : July 31, 2009
Information provided by:

July 30, 2009
July 31, 2009
July 31, 2009
May 2006
May 2011   (Final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 6 months ]
Same as current
No Changes Posted
  • Objective response rate [ Time Frame: Every 6 weeks while on study ]
  • Disease control rate [ Time Frame: 6 months ]
  • Safety profile of pemetrexed and erlotinib combination [ Time Frame: Continously ]
  • Assessment of molecular markers for biologic effects and predictive response [ Time Frame: while on study ]
Same as current
Not Provided
Not Provided
Pharmacodynamic Separation of Pemetrexed and Erlotinib as Second-line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
A Randomized Phase II Study of Schedule-Modulated Concomitant Pemetrexed and Erlotinib Versus Single Agent Pemetrexed in Patients With Progressive or Recurrent Non-Small Cell Lung Cancer (NSCLC)

RATIONALE: Erlotinib may stop the growth of tumor cells, and even shrink the tumors in some patients, by blocking some of the enzymes such as epidermal growth factor receptor (EGFR) needed for cell growth and spread. Pemetrexed is a drug that inhibits several key proteins that require folic acid to synthesize DNA. Blocking DNA synthesis in tumor cells has been shown to decrease tumor growth. can block tumor growth in different ways. Giving erlotinib together with pemetrexed at a specific schedule may kill more tumor cells than giving only pemetrexed.

PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib and cetuximab and to see how well they work in treating patients with advanced solid tumors or progressive or recurrent stage III or stage IV non-small cell lung cancer.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: Pemetrexed
    500 mg/m2 IV over 10 minutes on day 1 every 21 days
  • Drug: pemetrexed and erlotinib
    pemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days and erlotinib 150 mg PO once daily on days 2-17 every 21 days
  • Active Comparator: A
    Pemetrexed Monotherapy
    Intervention: Drug: Pemetrexed
  • Experimental: B
    Pharmacodynamic separation of pemetrexed and erlotinib
    Intervention: Drug: pemetrexed and erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
Not Provided
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed advanced (Stage IIIB with a malignant pleural effusion or Stage IV disease) or recurrent nonsquamous NSCLC.
  • Patients must have at least one measurable disease per RECIST criteria
  • Patient must have disease progression after one prior chemotherapy and/or targeted therapy other than pemetrexed or anti-EGFR therapy for metastatic disease, or relapse while receiving adjuvant therapy, or within 12 months of completing adjuvant therapy

Exclusion Criteria:

  • Patients who have had immunotherapy, hormone, chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Patients with uncontrolled brain metastases should be excluded from this clinical trial because of their poor prognosis.
  • Patients with immune deficiency
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Tianhong Li, MD, PhD, Montefiore Medical Center
Montefiore Medical Center
  • Eli Lilly and Company
  • OSI Pharmaceuticals
Study Chair: Tianhong Li, MD, PhD Montefiore Medical Center
Montefiore Medical Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP